Dental implants, tools, and methods

ABSTRACT

Apparatus is provided that includes a dental implant having a lateral external surface. The implant is shaped so as to define a lumen therethrough having a lateral opening through the lateral external surface. The apparatus further includes a retaining element, and a delivery tube having a distal tube end. The retaining element is configured to assume (a) a first position in which the retaining element removably couples the distal tube end to the implant such that the delivery tube is in fluid communication with the lumen via the lateral opening, and (b) a second position in which the retaining element does not couple the distal tube end to the implant. Other embodiments are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.13/314,818, filed Dec. 8, 2011, which is:

(a) a continuation-in-part of International ApplicationPCT/IL2010/000252, filed Mar. 24, 2010, which is a continuation-in-partof (i) U.S. application Ser. No. 12/485,199, filed Jun. 16, 2009, nowU.S. Pat. No. 8,029,284, and (ii) International ApplicationPCT/IL2009/000931, filed Sep. 29, 2009; and

(b) a continuation-in-part of U.S. application Ser. No. 13/040,440,filed Mar. 4, 2011, now U.S. Pat. No. 8,356,994, which is a continuationof U.S. application Ser. No. 12/240,353, filed Sep. 29, 2008, now U.S.Pat. No. 7,934,929.

All of the above-mentioned applications are assigned to the assignee ofthe present application and are incorporated herein by reference.

FIELD OF THE APPLICATION

The present invention relates generally to dental implants andimplantation methods, and specifically to minimally-invasive implantsand implantation methods for sinus lift and lateral ridge augmentationprocedures.

BACKGROUND OF THE APPLICATION

Osseointegrated dental implants are typically metallic or ceramic screwsthat are placed in the jawbone for supporting artificial teeth after theloss of natural teeth. Replacement of the maxillary teeth is often achallenging surgical procedure when the remaining maxillary bone hasinsufficient height to support the implant. One surgical technique foraugmenting the maxillary bone includes injecting a regenerativematerial, such as autogenic, allogeneic, xenogeneic, or synthetic bonegraft, into the vicinity of the maxillary bone. The regenerativematerial forms additional bone mass that integrates with the existingmaxillary bone, providing the necessary alveolar height to support theimplant.

Bone augmentation procedures are often surgically difficult to perform,and are associated with complications, including infection of themaxillary sinus. The top of the maxillary alveolar ridge forms the floorof the maxillary sinus, and is covered by a thin membrane known as theSchneiderian or subantral membrane. In one surgical procedure, known asa closed or internal sinus lift or elevation procedure, the surgeondrills a bore through the maxillary alveolar ridge from the oral cavityat the desired location of the implant. The bore penetrates the ridge tobelow the Schneiderian membrane. The surgeon injects the regenerativematerial through the bore to below the membrane, forming a cavitydefined by the top of the ridge and the bottom of the membrane, whichcavity occupies a portion of the space initially occupied by themaxillary sinus.

To prevent potentially serious complications, the surgeon must becareful not to perforate the Schneiderian membrane. This is oftendifficult, because of the delicacy of the membrane, and the restrictedaccess afforded by the closed approach.

SUMMARY OF APPLICATIONS

Some embodiments of the present invention provide a self-tappingosseointegrated dental implant and minimally-invasive closed sinus lifttechniques for augmenting the maxillary alveolar ridge while reducingthe risk of perforating the Schneiderian membrane and of infection. Thedental implant is shaped so as to define a lumen therethrough having adistal opening through a distal external surface of a distal portion ofthe implant. During an implantation procedure, a surgeon advances theimplant into a bore in the ridge until the distal implant end forms anopening through the top of the ridge to below the Schneiderian membrane,thereby bringing the distal opening into fluid communication with asurface of the membrane facing the ridge.

The surgeon gently lifts and separates the membrane from the top of theridge by injecting a fluid, such as saline solution, via the lumen, soas to form a cavity below the membrane between the ridge and themembrane. For some applications, the surgeon drains the fluid andinjects a regenerative material, such as liquid or gel bone graft, viathe lumen into the cavity. Alternatively, the surgeon does not drain thefluid, or drains the fluid but does not inject the regenerativematerial. The surgeon further screws the implant into the cavity. Afterbone grows in the cavity, a dental appliance, such as a crown, iscoupled to the implant.

For some applications, a proximal end of the lumen of the implant has alateral opening through a lateral external surface of the implant, andis not open to a proximal external surface of the implant within 2 mm ofthe proximal-most part of the implant. The implant typically ispermanently closed within 3 mm of the proximal-most part. During theimplantation procedure, the additional screwing of the implant into theregenerative material advances the lateral external surface of theimplant until the lateral opening is positioned entirely within the borein the ridge and/or within the cavity between the ridge and themembrane. Such positioning of both ends of the lumen within bone(current or future) substantially reduces the risk of infection, becausethe proximal end of the implant that is exposed to the oral cavity orgingiva is permanently closed.

For some applications, a delivery tube is coupled to the lumen via thelateral opening. After injecting the fluid, and, optionally, theregenerative material, into the cavity from the delivery tube via thelumen, the surgeon decouples the delivery tube from the implant beforefurther rotating the implant to bring the lateral opening entirelywithin the bore in the ridge and/or the cavity.

For some applications, a retaining element is provided, which isconfigured to assume a first position in which the retaining elementcouples a distal end of the delivery tube to the implant, and a secondposition in which the retaining element does not couple the distal tubeend to the implant. Typically, a sealing element is configured toremovably sealingly couple the delivery tube to the implant. For someapplications, a distal portion of the sealing element is conical.Alternatively or additionally, the distal tube end is embedded in thesealing element.

For some applications, an applicator is provided, which is removablycoupled to a proximal implant end of the implant. The retaining elementis coupled to the delivery tube and shaped so as to be removablycouplable to the proximal implant end via the applicator, such that theretaining element removably couples the distal tube end to the implantwhen the retaining element is removably coupled to the proximal end viathe applicator and is in the first position. For some applications, theretaining element comprises a retaining element body, a portion of whichis configured to be disposed alongside the implant, from the applicatorto the lateral opening of the implant. For some applications, theretaining element further comprises a shaft, which is configured suchthat rotation of the shaft brings the distal tube end into contact withthe lateral opening of the implant, to sealingly couple the distal tubeend to the lateral opening. The retaining element may be configured suchthat when the retaining element is in the first position, the shaft andthe distal tube end are positioned at circumferentially opposite sidesof the implant. Typically, the shaft is oriented such that alongitudinal axis thereof forms an angle of 90 degrees with alongitudinal axis of the implant. Optionally, an external surface of aportion of the shaft is shaped so as to define a screw thread, whichpasses through a lumen of the retaining element body that is shaped soas to define a corresponding screw thread.

For some applications, a minimally-invasive closed lateral ridgeaugmentation surgical procedure is provided for implanting a dentalimplant. The procedure is typically employed when a patient's maxillaryor mandibular alveolar ridge lacks sufficient bone width to support adental implant. A dental implant is shaped so as to define a lumentherethrough having at least one distal opening through a distalexternal surface, and a lateral opening through a lateral externalsurface of the implant. The surgeon forms a bore in bone of an alveolarridge, and inserts the implement into the bore at least until the distalopening comes into fluid communication with periosteal tissue covering alateral surface of the bone. Optionally, the surgeon attaches aretaining element to the implant, or to an applicator coupled to theimplant, and causes the retaining implant to removably sealingly couplea distal end of a delivery tube to the lateral opening. The surgeondelaminates the periosteal tissue from the bone by injecting a fluidthrough the lumen to form a cavity between the bone and the periostealtissue. After delaminating the periosteal tissue, the surgeon optionallyinjects a regenerative material into the cavity via the lumen.

There is therefore provided, in accordance with an application of thepresent invention, apparatus including:

a dental implant having a lateral external surface, the implant beingshaped so as to define a lumen therethrough having a lateral openingthrough the lateral external surface;

a delivery tube having a distal tube end; and

a retaining element, which is configured to assume (a) a first positionin which the retaining element removably couples the distal tube end tothe implant such that the delivery tube is in fluid communication withthe lumen via the lateral opening, and (b) a second position in whichthe retaining element does not couple the distal tube end to theimplant.

For some applications, the apparatus further includes a sealing element,which is configured to removably sealingly couple the delivery tube tothe implant when the retaining element is in the first position. Forexample, the sealing element may include an element selected from thegroup consisting of: an o-ring and a gasket. For some applications, adistal portion of the sealing element is conical. For some applications,the distal tube end is embedded in the sealing element.

For some applications, at least a portion of the retaining elementincludes a rigid material.

For some applications, at least a portion of the retaining element isdisposed at least 1.5 cm from the lateral opening when the retainingelement is in the first position.

For some applications, the retaining element is removably coupled to aproximal implant end of the implant, and coupled to the delivery tube.

For some applications, the apparatus further includes an applicator,which is removably coupled to a proximal implant end of the implant, andthe retaining element is coupled to the delivery tube and shaped so asto be removably couplable to the proximal implant end via theapplicator, such that the retaining element removably couples the distaltube end to the implant when the retaining element is removably coupledto the proximal end via the applicator and is in the first position.

For some applications, the retaining element includes a retainingelement body, a portion of which is configured to be disposed alongsidethe implant, from the applicator to the lateral opening of the implant,when the retaining element is removably coupled to the proximal implantend via the applicator. For some applications, the retaining elementfurther includes a shaft, which is configured such that rotation of theshaft brings the distal tube end into contact with the lateral openingof the implant, to sealingly couple the distal tube end to the lateralopening. For some applications, the retaining element is configured suchthat the shaft and the distal tube end are positioned atcircumferentially opposite sides of the implant, when the retainingelement is coupled to the proximal implant end via the applicator, andat least when the retaining element is in the first position. For someapplications, the retaining element is configured such that the shaftand the distal tube end are positioned at a same circumferential side ofthe implant, when the retaining element is coupled to the proximalimplant end via the applicator, and at least when the retaining elementis in the first position. For some applications, the shaft is orientedsuch that a longitudinal axis thereof forms an angle of 90 degrees witha longitudinal axis of the implant, when the retaining element iscoupled to the proximal implant end via the applicator, and at leastwhen the retaining element is in the first position. For someapplications, an external surface of a portion of the shaft is shaped soas to define a screw thread, which passes through a lumen of theretaining element body that is shaped so as to define a correspondingscrew thread.

For some applications, the retaining element further includes a shaft, afirst end of which serves as the distal tube end, which shaft isconfigured to sealingly couple the distal tube end to the lateralopening of the implant. For some applications, the shaft is configuredsuch that rotation of a portion thereof brings the distal tube end intocontact with the lateral opening of the implant.

For some applications, the retaining element is shaped so as to beremovably couplable to the applicator, such that the retaining elementremovably couples the distal tube end to the implant when the applicatoris removably coupled to the proximal implant end, and the retainingelement is removably coupled to the applicator in the first position.For some applications, the applicator is shaped so as to define alongitudinal portion that is shaped so as to define an external surfacethat is rotationally asymmetric. For some applications, the retainingelement is shaped such that the rotationally-asymmetric surface of theapplicator constrains a rotational orientation of the retaining elementto a single rotational orientation with respect to the applicator, androtationally aligns the distal tube end with the lateral opening of theimplant.

For some applications, the retaining element is fixed to the applicator.

For some applications, the applicator further includes a spring, whichis configured to apply a force that separates the distal tube end fromthe implant when the retaining element assumes the second position.

For some applications, the lumen is not open to a proximal externalsurface of the implant within 2 mm of a proximal-most part of theimplant. For some applications, the implant has a distal implant portionthat extends from a distal implant end along up to 50% of a longitudinallength of the implant, and the lumen has at least one distal openingthrough a distal external surface of the distal implant portion. Forsome applications, the implant is shaped such that the lumen definesexactly one lateral opening through the lateral external surface.

For some applications, the apparatus further includes an applicator,which is removably coupled to a proximal implant end of the implant.

For some applications, the distal tube end is not welded to the implant.

For some applications, the retaining element is configured torotationally align the distal tube end with the lateral opening when theretaining element assumes the first position.

For some applications, when the delivery tube is removably coupled tothe implant, a portion of the delivery tube runs alongside the implantsuch that a greatest distance between a longitudinal axis of the implantand a surface of the portion of the delivery tube farthest from thelongitudinal axis is less than 7 mm.

For some applications, a proximal end of the implant is shaped so as todefine an abutment-coupling surface. For some applications, theapparatus further includes an abutment, which is configured to becoupled to the abutment-coupling surface. Alternatively, for someapplications, the implant is shaped so as to define an integratedabutment.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a dental implant having a lateral external surface, the implant beingshaped so as to define a lumen therethrough having a lateral openingthrough the lateral external surface;

a delivery tube having a distal tube end, which distal tube end isremovably coupled to the implant such that the delivery tube is in fluidcommunication with the lumen via the lateral opening; and

a fixing element and a fixing element receptor, which are configured tobe temporarily coupled together so as to prevent decoupling of thedelivery tube from the implant.

For some applications, the apparatus further includes an applicator,which is removably coupled to a proximal implant end of the implant, andwhich is shaped so as to define the fixing element receptor. For someapplications, the applicator is configured such that removal of theapplicator from the implant frees the fixing element from the fixingelement receptor.

For some applications, the delivery tube includes the fixing element.

For some applications, the fixing element and the fixing elementreceptor are configured, when temporarily coupled together, to preventrotation of the delivery tube with respect to the implant.

For some applications, the fixing element is shaped so as to define afixing pin, and the fixing element receptor is shaped so as to define areceptor hole.

For some applications, the fixing element is shaped so as to define ashape selected from the group consisting of: a slot and a groove, andthe fixing element receptor is shaped so as to define a correspondingcoupling surface that fixes the fixing element to the fixing elementreceptor.

For some applications, the distal tube end is removably coupled to theimplant by being welded to the implant.

There is still further provided, in accordance with an application ofthe present invention, apparatus including:

a dental implant having a lateral external surface, the implant beingshaped so as to define a lumen therethrough having a lateral openingthrough the lateral external surface; and

a delivery tube having a distal tube end, which distal tube end isremovably coupled to the implant at a first interface, such that thedelivery tube is in fluid communication with the lumen via the lateralopening,

wherein the delivery tube is removably coupled to the implant at asecond interface remote from the first interface, so as to preventmovement of the distal tube end with respect to the implant.

For some applications, the delivery tube is directly removably coupledto the implant at the second interface. Alternatively, the delivery tubeis indirectly removably coupled to the implant at the second interface.For some applications, the apparatus further includes an applicator,which (a) is removably coupled to a proximal implant end of the implantat the second interface, and (b) indirectly removably couples thedelivery tube to the implant.

For some applications, the delivery tube is removably coupled to theimplant at the second interface, so as to prevent rotation of the distaltube end with respect to the implant.

For some applications, the distal tube end is removably coupled to theimplant by being welded to the implant.

There is additionally provided, in accordance with an application of thepresent invention, apparatus including:

a dental implant; and

a dental applicator, which is shaped so as to define:

-   -   a distal coupling surface, which is configured to removably        engage the applicator with a proximal end of the dental implant,    -   a proximal coupling surface, and    -   a longitudinal portion, which is shaped so as to define an        external surface that is rotationally asymmetric,    -   wherein the distal and the proximal coupling surfaces share a        common central longitudinal axis.

For some applications, the apparatus further includes a retainingelement, which is removably coupleable to the applicator, and which isshaped such that the rotationally-asymmetric surface of the applicatorconstrains a rotational orientation of the retaining element to a singlerotational orientation with respect to the applicator.

For some applications, the distal coupling surface extends from a distalend of the applicator toward the proximal coupling surface.

Alternatively or additionally, for some applications, the proximalcoupling surface extends from a proximal end of the applicator towardthe distal coupling surface. For some applications, the distal couplingsurface extends from a distal end of the applicator toward the proximalcoupling surface.

For some applications, the distal coupling surface is rotationallysymmetric and not circular. For example, the distal coupling surface maybe regularly polygonally shaped. Alternatively or additionally, for someapplications, the proximal coupling surface is rotationally symmetricand not circular. For example, the proximal coupling surface may beregularly polygonally shaped.

For some applications, each of the distal and the proximal couplingsurfaces is rotationally symmetric and not circular. For example, thedistal and the proximal coupling surface may be regularly polygonallyshaped.

For some applications, the distal coupling surface is longitudinallynon-overlapping with the rotationally-asymmetric external surface.Alternatively or additionally, for some applications, the proximalcoupling surface is longitudinally non-overlapping with therotationally-asymmetric external surface. For some applications, thedistal and the proximal coupling surfaces are longitudinallynon-overlapping with the rotationally-asymmetric external surface. Forexample, the distal and the proximal coupling surfaces may be male andregularly polygonally shaped.

For some applications, the distal coupling surface is male or female.Alternatively or additionally, for some applications, the proximalcoupling surface is male or female.

For some applications, the applicator is shaped so as to define achannel therethrough, which is open to both distal and proximal ends ofthe applicator, and which is coaxial with the central longitudinal axis.For some applications, the applicator includes a connecting element,which is configured to be disposed at least partially in the channel,and to removably couple the applicator to the proximal implant end. Forsome applications, the connecting element includes a shaft, at least aportion of which defines a screw thread.

For some applications, the rotationally-asymmetric external surfaceextends from a distal end of the applicator toward a proximal end of theapplicator. Alternatively or additionally, for some applications, therotationally-asymmetric external surface extends from a proximal end ofthe applicator toward a distal end of the applicator.

There is yet additionally provided, in accordance with an application ofthe present invention, a method including:

providing (a) a dental implant having a lateral external surface, theimplant being shaped so as to define a lumen therethrough having alateral opening through the lateral external surface, (b) a deliverytube having a distal tube end, and (c) a retaining element;

causing the retaining element to assume a first position in which theretaining element removably couples the distal tube end to the implantsuch that the delivery tube is in fluid communication with the lumen viathe lateral opening; and

causing the retaining element to assume a second position in which theretaining element does not couple the distal tube end to the implant.

For some applications, causing the retaining element to assume thesecond position includes causing the retaining element to assume thesecond position after causing the retaining element to assume the firstposition. Alternatively or additionally, for some applications, causingthe retaining element to assume the second position includes causing theretaining element to assume the second position before causing theretaining element to assume the first position.

For some applications, the lumen has at least one distal opening througha distal external surface of the implant, and the method furtherincludes:

forming a bore through a maxillary alveolar ridge;

inserting the implant into the bore at least until the distal openingcomes into fluid communication with a surface of a Schneiderian membranefacing the ridge;

raising the membrane to form a cavity between the ridge and themembrane, by injecting a liquid through the lumen via the delivery tubewhen the retaining element is in the first position such that the distaltube end is removably coupled to the implant;

decoupling the distal tube end from the implant by transitioning theretaining element from the first position to the second position; and

further rotating the implant until the lateral opening is positionedentirely within at least one location selected from the group consistingof: the bore in the ridge, and the cavity between the ridge and themembrane.

For some applications, the method further includes providing a sealingelement, which is configured to removably sealingly couple the deliverytube to the implant when the retaining element is in the first position.For some applications, the sealing element includes an element selectedfrom the group consisting of: an o-ring and a gasket. For someapplications, a distal portion of the sealing element is conical. Forsome applications, the distal tube end is embedded in the sealingelement.

For some applications, providing the retaining element includesproviding the retaining element in which at least a portion thereofincludes a rigid material.

For some applications, at least a portion of the retaining element isdisposed at least 1.5 cm from the lateral opening when the retainingelement is in the first position.

For some applications, the retaining element is coupled to the deliverytube, and the method further includes removably coupling the retainingelement to a proximal implant end of the implant.

For some applications, causing the retaining element to assume the firstposition includes removably coupling the retaining element to a proximalimplant end of the implant via an applicator removably coupled to theproximal implant end, and causing the retaining element to assume thefirst position. For some applications, removably coupling the retainingelement to the proximal implant end via the applicator includesdisposing a portion of a retaining element body of the retaining elementalongside the implant from the applicator to the lateral opening of theimplant.

For some applications, the retaining element further includes a shaft,and causing the retaining element to assume the first position includesrotating the shaft to bring the distal tube end into contact with thelateral opening of the implant, to sealingly couple the distal tube endto the lateral opening. For some applications, removably coupling theretaining element to proximal implant end via the applicator includespositioning the shaft and the distal tube end at circumferentiallyopposite sides of the implant. For some applications, removably couplingthe retaining element to proximal implant end via the applicatorincludes positioning the shaft and the distal tube end at a samecircumferential side of the implant.

For some applications, the retaining element includes a shaft, a firstend of which serves as the distal tube end, and causing the retainingelement to assume the first position includes using the shaft tosealingly couple the distal tube end to the lateral opening of theimplant. For some applications, causing the retaining element to assumethe first position includes rotating the shaft to bring the distal tubeend into contact with the lateral opening of the implant.

For some applications, removably coupling the retaining element to theproximal implant end via the applicator includes removably coupling theretaining element to the applicator. For some applications, theapplicator is shaped so as to define a longitudinal portion that isshaped so as to define an external surface that is rotationallyasymmetric. For some applications, the retaining element is shaped suchthat the rotationally-asymmetric surface of the applicator constrains arotational orientation of the retaining element to a single rotationalorientation with respect to the applicator.

For some applications, providing the retaining element includesproviding the retaining element fixed to an applicator that is removablycoupled to a proximal implant end of the implant.

For some applications, providing the implant includes providing theimplant including a distal implant portion that extends from a distalimplant end along up to 50% of a longitudinal length of the implant, andthe lumen has at least one distal opening through a distal externalsurface of the distal implant portion.

For some applications, providing the implant includes providing theimplant in which the lumen is not open to a proximal external surface ofthe implant within 2 mm of a proximal-most part of the implant.

For some applications, providing the implant includes providing theimplant shaped such that the lumen defines exactly one lateral openingthrough the lateral external surface.

There is also provided, in accordance with an application of the presentinvention, a method including:

providing (a) a dental implant having a lateral external surface, theimplant being shaped so as to define a lumen therethrough having alateral opening through the lateral external surface, and (b) a deliverytube having a distal tube end;

removably coupling the distal tube end to the implant at a firstinterface, such that the delivery tube is in fluid communication withthe lumen via the lateral opening; and

removably coupling the delivery tube to the implant at a secondinterface remote from the first interface, so as to prevent movement ofthe distal tube end with respect to the implant.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a dental implant having a lateral external surface, the implant beingshaped so as to define a lumen therethrough having a lateral openingthrough the lateral external surface; and

a delivery tube having a distal tube end, which is removably coupled tothe implant such that the delivery tube is in fluid communication withthe lumen via the lateral opening.

For some applications, the lumen is not open to a proximal externalsurface of the implant within 2 mm of a proximal-most part of theimplant. For some applications, the implant has a distal implant portionthat extends from a distal implant end along up to 50% of a longitudinallength of the implant, and the lumen has at least one distal openingthrough a distal external surface of the distal implant portion. Forsome applications, the implant is shaped such that the lumen definesexactly one lateral opening through the lateral external surface. Forsome applications, when the delivery tube is coupled to the implant, aportion of the delivery tube runs alongside the implant such that agreatest distance between a longitudinal axis of the implant and asurface of the portion of the delivery tube farthest from thelongitudinal axis is less than 7 mm, such as less than 6 mm.

For some applications, the distal tube end is welded to the implant,such that application of a breaking torque to the delivery tube breaksthe delivery tube, thereby decoupling the delivery tube from theimplant. For some applications, a portion of a wall of the delivery tubeis thinner than the wall immediately adjacent to the portion, such thatapplication of the breaking torque to the delivery tube breaks thedelivery tube at the thinner portion. Typically, the thinner portion iswithin 3 mm of the distal tube end. For example the delivery tube may beshaped so as to be circumscribed with a groove that defines the thinnerportion.

For some applications in which the distal tube end is welded to theimplant, the apparatus further includes a rotation breaking tool, whichis configured to be temporarily coupled to the dental implant, and tobreak the delivery tube by rotating the distal tube end with respect tothe lateral opening, thereby applying the breaking torque to thedelivery tube. For some applications, the apparatus further includes anapplicator, which is removably coupled to a proximal implant end of theimplant. For some applications, the rotation breaking tool is configuredto be temporarily coupled to the proximal implant end after theapplicator is decoupled therefrom. For some applications, the applicatoris configured to prevent application of the breaking torque to thedelivery tube when the applicator is coupled to the proximal implantend. For some applications, the applicator is configured to preventrotation of the distal tube end with respect to the lateral opening whenthe applicator is coupled to the proximal implant end. For someapplications, the delivery tube includes a fixing element, theapplicator includes a fixing element receptor, and, when the applicatoris coupled to the proximal implant end, at least a portion of the fixingelement is coupled to the fixing element receptor, thereby preventingthe rotation of the distal tube end.

For some applications, the rotation breaking tool includes: a handle; acoupling element, which is positioned near a distal end of the handle,and which is configured to be coupled to the implant; and a breakingelement, which is configured to apply the breaking torque to thedelivery tube. For some applications, the rotation breaking tool furtherincludes a rotating member, to which the breaking element is coupled,and which rotating member rotates with respect to the handle around thecoupling element, and the coupling element remains stationary withrespect to the handle even when the rotating member is rotated. For someapplications, a longitudinal axis of the handle forms an angle ofbetween 70 and 90 degrees with a longitudinal axis of the couplingelement, such as 90 degrees.

Alternatively, a longitudinal axis of the handle forms an angle ofbetween 0 and 30 degrees with a longitudinal axis of the couplingelement, e.g., the longitudinal axis of the handle is parallel to thelongitudinal axis of the coupling element. For some applications, thehandle includes: a rotating sub-handle, which is in mechanicalcommunication with the rotating member; and a stationary sub-handle,which is in mechanical communication with the coupling element. For someapplications, the handle further includes: a rotating shaft, whichprovides the mechanical communication between the rotating sub-handleand the rotating member; and a stationary shaft, which provides themechanical communication between the stationary sub-handle and thecoupling element. For some applications, the handle is arranged suchthat the stationary shaft passes through the rotating shaft.Alternatively, the handle is arranged such that the rotating shaftpasses through the stationary shaft.

For some applications in which the distal tube end is welded to theimplant, the apparatus further includes an applicator, which isremovably coupled to a proximal implant end of the implant, and which isconfigured to break the delivery tube by rotating the distal tube endwith respect to the lateral opening. For some applications, theapplicator is configured to apply a torque of greater than 50 Newtoncentimeters to the delivery tube, when rotating the distal tube end withrespect to the lateral opening. For some applications, the applicatorincludes a lever arm, which is coupled to the delivery tube and arrangedto rotate the distal tube end with respect to the lateral opening. Forsome applications, the applicator includes a rotatable surfaceaccessible from a proximal end of the applicator, which rotatablesurface is rotatable with respect to a portion of the applicator,rotation of which rotatable surface rotates the distal tube end byextending the lever arm. For some applications, the applicator includes:a connecting screw, which removably couples the applicator to theproximal implant end; and a rotatable surface accessible from a proximalend of the applicator, which rotatable surface is rotatable with respectto a portion of the applicator, and the applicator is configured suchthat rotation of the rotatable surface both (a) applies the breakingtorque to the delivery tube that breaks the delivery tube, and (b)rotates the screw to decouple the applicator from the proximal implantend.

For some applications (in which the distal tube end is typically notwelded to the implant), the apparatus further includes a retainingelement, which is configured to assume a first position in which theretaining element couples the distal tube end to the implant, and asecond position in which the retaining element does not couple thedistal tube end to the implant. For some applications, the apparatusfurther includes a sealing element, which is configured to removablysealingly couple the delivery tube to the implant. For someapplications, the retaining element is removably coupled to a proximalimplant end of the implant, and coupled to the delivery tube.

For some applications in which the apparatus includes the retainingelement, the apparatus further includes an applicator, which isremovably coupled to a proximal implant end of the implant, and theretaining element is removably couplable to the applicator, and coupledto the delivery tube. For some applications, the retaining elementincludes a retaining element body, a portion of which is configured tobe disposed alongside the implant, from the applicator to the lateralopening of the implant. For some applications, the retaining elementfurther includes a shaft. For some applications, the shaft is configuredsuch that rotation thereof brings the distal tube end into contact withthe lateral opening of the implant.

For some applications in which the apparatus includes the retainingelement, the apparatus further includes an applicator, which isremovably coupled to a proximal implant end of the implant, and theretaining element is fixed to the applicator, and coupled to thedelivery tube. For some applications, the distal tube end is shaped soas to define a cone. For some applications, the cone has an openingangle of between 0 and 60 degrees. For some applications, the cone isshaped so as to define a Morse taper. For some applications, thedelivery tube is configured to pivot with respect to the applicator. Forsome applications, the applicator further includes a spring, which isconfigured to apply a force that separates the distal tube end from theimplant when the retaining element assumes the second position.

There is further provided, in accordance with an application of thepresent invention, a method including:

forming a bore through a maxillary alveolar ridge;

inserting an implant into the bore at least until the distal openingcomes into fluid communication with a surface of a Schneiderian membranefacing the ridge, which implant is shaped so as to define a lumentherethrough (a) having at least one distal opening through a distalexternal surface of the implant, and (b) having a lateral openingthrough a lateral external surface of the implant;

raising the membrane to form a cavity between the ridge and themembrane, by injecting a liquid through the lumen via a delivery tubehaving a distal tube end that is removably coupled to the implant suchthat the delivery tube is in fluid communication with the lumen via thelateral opening;

decoupling the distal tube end from the implant; and

further rotating the implant until the lateral opening is positionedentirely within at least one location selected from the group consistingof: the bore in the ridge, and the cavity between the ridge and themembrane.

For some applications, the lumen is not open to a proximal externalsurface of the implant within 2 mm of a proximal-most part of theimplant. For some applications, the implant is shaped such that thelumen defines exactly one lateral opening through the lateral externalsurface.

For some applications, the distal tube end is welded to the implant, anddecoupling the distal tube end from the implant includes breaking thedelivery tube by applying a breaking torque to the delivery tube. Forsome applications, a portion of a wall of the delivery tube is thinnerthan the wall immediately adjacent to the portion, and breaking thedelivery tube includes breaking the delivery tube at the thinner portionby applying the breaking torque to the delivery tube. Typically, thethinner portion is within 3 mm of the distal tube end. For example, thedelivery tube may be shaped so as to be circumscribed with a groove thatdefines the thinner portion.

For some applications in which the distal tube end is welded to theimplant, applying the breaking torque includes: temporarily coupling arotation breaking tool to the implant; breaking the delivery tube byusing the rotation breaking tool to rotate the distal tube end withrespect to the lateral opening, thereby applying the breaking torque tothe delivery tube; and decoupling the rotation breaking tool from theimplant.

For some applications, inserting the implant includes inserting theimplant with an applicator removably coupled to a proximal implant endof the implant, and temporarily coupling the rotation breaking tool tothe implant includes temporarily coupling the rotation breaking tool tothe proximal implant end after decoupling the applicator therefrom. Forsome applications, the applicator is configured to prevent applicationof the breaking torque to the delivery tube when the applicator iscoupled to the proximal implant end. For some applications, theapplicator is configured to prevent rotation of the distal tube end withrespect to the lateral opening when the applicator is coupled to theproximal implant end. For some applications, the delivery tube includesa fixing element, the applicator includes a fixing element receptor,and, when the applicator is coupled to the proximal implant end, atleast a portion of the fixing element is coupled to the fixing elementreceptor, thereby preventing the rotation of the distal tube end.

For some applications, the rotation breaking tool includes (a) a handle,(b) a coupling element, which is positioned near a distal end of thehandle, and (c) a breaking element, coupling the rotation breaking toolto the implant includes coupling the coupling element to the implant,and applying the breaking torque to the delivery tube includes using thebreaking element to apply the breaking torque to the delivery tube. Forsome applications, the rotation breaking tool further includes arotating member, to which the breaking element is coupled, and applyingthe breaking torque includes rotating the rotating member rotates withrespect to the handle around the coupling element, while the couplingelement remains stationary with respect to the handle.

For some applications, a longitudinal axis of the handle forms an angleof between 70 and 90 degrees with a longitudinal axis of the couplingelement, such as 90 degrees. Alternatively, a longitudinal axis of thehandle forms an angle of between 0 and 30 degrees with a longitudinalaxis of the coupling element, e.g., the longitudinal axis of the handleis parallel to the longitudinal axis of the coupling element.

For some applications in which the distal tube end is welded to theimplant, inserting the implant includes inserting the implant with anapplicator removably coupled to a proximal implant end of the implant,and applying the breaking torque includes using the applicator rotatethe distal tube end with respect to the lateral opening.

For some applications in which the distal tube end is welded to theimplant, applying the breaking torque includes grasping the deliverytube with a human hand, and applying the breaking torque using the hand.

For some applications in which the distal tube end is welded to theimplant, applying the breaking torque includes bringing a tool intocontact with the delivery tube, and applying the breaking torque usingthe tool. For some applications, bringing the tool into contact includesgrasping the delivery tube with the tool.

For some applications (in which the distal tube end is typically notwelded to the implant), the method further includes providing aretaining element, which is configured to assume a first position inwhich the retaining element couples the distal tube end to the implant,and a second position in which the retaining element does not couple thedistal tube end to the implant.

For some applications, raising the membrane includes removably couplingthe retaining element to an applicator coupled to a proximal implant endof the implant, and causing the retaining element to assume the firstposition. For some applications, coupling the retaining element to theapplicator including disposing a portion of a retaining element body ofthe retaining element alongside the implant from the applicator to thelateral opening of the implant. For some applications, the retainingelement includes a shaft, a first end of which serves as the distal tubeend, and coupling the distal tube end to the implant includes using theshaft to sealingly couple the distal tube end to the lateral opening ofthe implant. For some applications, coupling the distal tube end to theimplant includes rotating the shaft to bring the distal tube end intocontact with the lateral opening of the implant.

For some applications, providing the retaining element includesproviding the retaining element (a) fixed to an applicator that iscoupled to a proximal implant end of the implant, and (b) coupled to thedelivery tube.

There is still further provided, in accordance with an application ofthe present invention, apparatus including:

a dental implant having a lateral external surface, the implant beingshaped so as to define a lumen therethrough having a lateral openingthrough the lateral external surface; and

a delivery tube having a distal tube end, which is removably coupled tothe implant such that the delivery tube is in fluid communication withthe lumen via the lateral opening,

wherein the distal tube end is welded to the implant, such thatapplication of a breaking torque to the delivery tube breaks thedelivery tube, thereby decoupling the delivery tube from the implant.

For some applications, the lumen is not open to a proximal externalsurface of the implant within 2 mm of a proximal-most part of theimplant. For some applications, the implant has a distal implant portionthat extends from a distal implant end along up to 50% of a longitudinallength of the implant, and the lumen has at least one distal openingthrough a distal external surface of the distal implant portion. Forsome applications, the implant is shaped such that the lumen definesexactly one lateral opening through the lateral external surface. Forsome applications, when the delivery tube is coupled to the implant, aportion of the delivery tube runs alongside the implant such that agreatest distance between a longitudinal axis of the implant and asurface of the portion of the delivery tube farthest from thelongitudinal axis is less than 7 mm, such as less than 6 mm.

For some applications, a portion of a wall of the delivery tube isthinner than the wall immediately adjacent to the portion, such thatapplication of the breaking torque to the delivery tube breaks thedelivery tube at the thinner portion. Typically, the thinner portion iswithin 3 mm of the distal tube end. For example, the delivery tube maybe shaped so as to be circumscribed with a groove that defines thethinner portion.

For some applications, the apparatus further includes a rotationbreaking tool, which is configured to be temporarily coupled to thedental implant, and to break the delivery tube by rotating the distaltube end with respect to the lateral opening, thereby applying thebreaking torque to the delivery tube. For some applications, theapparatus further includes an applicator, which is removably coupled toa proximal implant end of the implant. For some applications, therotation breaking tool is configured to be temporarily coupled to theproximal implant end after the applicator is decoupled therefrom. Forsome applications, the applicator is configured to prevent applicationof the breaking torque to the delivery tube when the applicator iscoupled to the proximal implant end. For some applications, theapplicator is configured to prevent rotation of the distal tube end withrespect to the lateral opening when the applicator is coupled to theproximal implant end. For some applications, the delivery tube includesa fixing element, the applicator includes a fixing element receptor,and, when the applicator is coupled to the proximal implant end, atleast a portion of the fixing element is coupled to the fixing elementreceptor, thereby preventing the rotation of the distal tube end.

For some applications, the rotation breaking tool includes: a handle; acoupling element, which is positioned near a distal end of the handle,and which is configured to be coupled to the implant; and a breakingelement, which is configured to apply the breaking torque to thedelivery tube. For some applications, the rotation breaking tool furtherincludes a rotating member, to which the breaking element is coupled,and which rotating member rotates with respect to the handle around thecoupling element, and the coupling element remains stationary withrespect to the handle even when the rotating member is rotated.

For some applications, a longitudinal axis of the handle forms an angleof between 70 and 90 degrees with a longitudinal axis of the couplingelement, such as 90 degrees. Alternatively, a longitudinal axis of thehandle forms an angle of between 0 and 30 degrees with a longitudinalaxis of the coupling element, e.g., the longitudinal axis of the handleis parallel to the longitudinal axis of the coupling element. For someapplications, the handle includes: a rotating sub-handle, which is inmechanical communication with the rotating member; and a stationarysub-handle, which is in mechanical communication with the couplingelement. For some applications, the handle further includes: a rotatingshaft, which provides the mechanical communication between the rotatingsub-handle and the rotating member; and a stationary shaft, whichprovides the mechanical communication between the stationary sub-handleand the coupling element. For some applications, the handle is arrangedsuch that the stationary shaft passes through the rotating shaft.Alternatively, the handle is arranged such that the rotating shaftpasses through the stationary shaft.

For some applications, the apparatus further includes an applicator,which is removably coupled to a proximal implant end of the implant, andwhich is configured to break the delivery tube by rotating the distaltube end with respect to the lateral opening. For some applications, theapplicator is configured to apply a torque of greater than 50 Newtoncentimeters to the delivery tube, when rotating the distal tube end withrespect to the lateral opening. For some applications, the applicatorincludes a lever arm, which is coupled to the delivery tube and arrangedto rotate the distal tube end with respect to the lateral opening. Forsome applications, the applicator includes a rotatable surfaceaccessible from a proximal end of the applicator, which rotatablesurface is rotatable with respect to a portion of the applicator,rotation of which rotatable surface rotates the distal tube end byextending the lever arm. For some applications, the applicator includes:a connecting screw, which removably couples the applicator to theproximal implant end; and a rotatable surface accessible from a proximalend of the applicator, which rotatable surface is rotatable with respectto a portion of the applicator, and the applicator is configured suchthat rotation of the rotatable surface both (a) applies the breakingtorque to the delivery tube that breaks the delivery tube, and (b)rotates the screw to decouple the applicator from the proximal implantend.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-C are schematic illustrations of a dental implant system, inaccordance with an embodiment of the present invention;

FIGS. 2A-C are schematic illustrations of alternative configurations ofa dental implant of the dental implant system of FIGS. 1A-C, inaccordance with respective applications of the present invention;

FIGS. 3A-D are schematic illustrations of alternative configurations ofthe implant of FIGS. 1A-C and an applicator in which the distal end of adelivery tube is initially removably coupled to the implant, inaccordance with respective applications of the present invention;

FIG. 4 is a schematic illustration of a rotation breaking tool, inaccordance with an application of the present invention;

FIGS. 5A-B are schematic side-views of the rotation breaking tool ofFIG. 4, in accordance with an application of the present invention;

FIGS. 6A-B are schematic illustrations of the rotation breaking tool ofFIG. 4 coupled to the implant of FIGS. 1A-C, in accordance with anapplication of the present invention;

FIG. 7 is a schematic illustration of another configuration of arotation breaking tool, in accordance with an application of the presentinvention;

FIGS. 8A-B are schematic illustrations of the rotation breaking tool ofFIG. 7 coupled to the implant of FIGS. 1A-C, in accordance with anapplication of the present invention;

FIGS. 9A-B are schematic isometric and cross-sectional illustrations,respectively, of yet another configuration of a rotation breaking tool,in accordance with an application of the present invention;

FIGS. 10A-B are schematic illustrations of a first component of thebreaking tool of FIGS. 9A-B, in accordance with an application of thepresent invention;

FIGS. 11A-D are schematic illustrations of a second component of thebreaking tool of FIGS. 9A-B, in accordance with an application of thepresent invention;

FIG. 12 is a schematic illustration of still another configuration of arotation breaking tool, in accordance with an application of the presentinvention;

FIG. 13 is a schematic cross-sectional illustration of the rotationbreaking tool of FIG. 12, in accordance with an application of thepresent invention;

FIG. 14 is a schematic cross-sectional illustration of a distal end ofthe rotation breaking tool of FIG. 12, in accordance with an applicationof the present invention;

FIG. 15 is a schematic illustration of a dental implant and anapplicator comprising a retaining element in a first position, inaccordance with an application of the present invention;

FIG. 16 is a schematic cross-sectional illustration of the implant andapplicator of FIG. 15, in accordance with an application of the presentinvention;

FIGS. 17A-E are schematic views from respective directions of theimplant and applicator of FIG. 15 in a second position, in accordancewith an application of the present invention;

FIG. 18 is a schematic cross-sectional view of FIG. 17A, in accordancewith an application of the present invention;

FIGS. 19A-C are schematic illustrations of another configuration of adental implant, an applicator, and a retaining element in a secondposition, in accordance with an application of the present invention;

FIG. 19D is a schematic illustration of the implant, applicator andretaining element of FIGS. 19A-C in a first position, in accordance withan application of the present invention;

FIGS. 20A-G are schematic illustrations of yet another configuration ofthe implant, the applicator, and the retaining element of FIGS. 19A-D,in accordance with an application of the present invention;

FIGS. 21A-D, 22A-B, 23, and 24 are schematic illustrations of a dentalimplant and an applicator in which the distal end of a delivery tube isinitially welded to the implant, in accordance with an application ofthe present invention;

FIGS. 25A-G are schematic illustrations of several steps of aminimally-invasive closed sinus lift surgical procedure for implanting adental implant, in accordance with an application of the presentinvention;

FIGS. 25H-J are schematic illustration of alternative techniques forinjecting regenerative material, in accordance with an application ofthe present invention;

FIGS. 26A-B are schematic illustrations of several steps of anotherminimally-invasive closed sinus lift surgical procedure for implanting adental implant, in accordance with an application of the presentinvention;

FIGS. 27A and 27B are schematic illustrations of tools and techniques,respectively, for decoupling a delivery tube from the implant of FIGS.21A-24, in accordance with an application of the present invention;

FIGS. 27C and 27D-E are schematic illustrations of a tool andtechniques, respectively, for decoupling the applicator from the implantof FIGS. 21A-24, in accordance with an application of the presentinvention;

FIGS. 28A-B are schematic lateral and head-on illustrations,respectively, of a configuration of a distal surface of the dentalimplant of FIGS. 1A-C, in accordance with an application of the presentinvention;

FIGS. 29A-F are schematic illustrations of several steps of aminimally-invasive closed lateral ridge augmentation surgical procedurefor implanting a dental implant, in accordance with an application ofthe present invention;

FIG. 30 is a schematic illustration of a configuration of a sealingelement of a retaining element, in accordance with an application of thepresent invention;

FIG. 31 is a schematic illustration of a removable coupling elementcoupled to a dental implant, in accordance with an embodiment of thepresent invention;

FIGS. 32A-C are schematic illustrations of an implant and a dentalapplicator, in accordance with an application of the present invention;and

FIG. 33 is a schematic cross-sectional illustration showing a retainingelement removably coupled to the applicator of FIGS. 32A-C, inaccordance with an application of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

FIGS. 1A-C are schematic illustrations of a dental implant system 20, inaccordance with an embodiment of the present invention. FIGS. 1A-B areisometric views of the system, and FIG. 1C is a cross-sectional view ofFIG. 1A along line IC-IC. System 20 comprises a dental implant 30, whichis typically shaped so as to define a lumen 40 therethrough that is openthrough a distal opening 41 to a distal portion 48 of the implant thatextends from a distal implant end 38 of the implant along up to 50% of alongitudinal length of the implant, such as up to 30% of the length, upto 15% of the length, or up to 5% of the length. For some applications,distal portion 48 has a longitudinal length of up to 8 mm, such as up to6 mm, up to 4 mm, or up to 2 mm, e.g., 5 mm or 8 mm. As used herein,including in the claims, the “distal” end of the implant is the end thatis inserted first into a bone, such as an alveolar ridge, and issometimes referred to in the art as the apical end, and the “proximal”end of the implant is the end of the implant opposite the distal end,e.g., that faces the oral cavity, and is sometimes referred to in theart as the coronal end. Similarly, “distal” means situated toward thedistal end of the implant, and “proximal” means situated toward theproximal end of the implant.

Distal opening 41 may be located at distal implant end 38, such ascentered on the distal implant end, e.g., at a distal tip of distalimplant end 38, or not centered on the distal implant end (and thuslocated at a location other than the distal tip), such as describedhereinbelow with reference to FIG. 2A. Alternatively, distal opening(s)41 may be located at one or more locations along distal implant portion48, including at locations on lateral surface 42. For some applications,the lumen is open to the distal end via a plurality of openings 41,which for some applications results in a more even distribution ofregenerative material in the cavity between the ridge and theSchneiderian membrane, as described hereinbelow, and/or permits passageof the regenerative material even if some of the openings should becomeblocked with bone particles. Dental implant 30 is typically generallycylindrical, tapered, or conic in shape, other than the lumen, andtypically comprises a metal such as titanium, or a ceramic, such as azirconia (zirconium dioxide) ceramic. The implant may have a greatestdiameter of between about 2 and about 7 mm, and may be provided in avariety of longitudinal lengths, e.g., between about 7 and about 18 mm,e.g., between about 12 and about 16 mm, such as about 15 mm. For someapplications, the implant has a longitudinal length of less than 20 mmand a greatest diameter of less than 10 mm.

For some applications, dental implant 30 comprises a self-tappingosseointegrated dental implant. For these applications, at least aportion of a lateral external surface 42 of implant 30 is typicallyshaped so as to define a cutting surface, e.g., a screw thread 36, orother connecting element. For example, the portion may be in a vicinityof a distal end 38 of the implant, or may include all or nearly all ofthe lateral surface.

For some applications, system 20 comprises an applicator 32 that isremovably coupled to a proximal end 34 of implant 30. For someapplications, applicator 32 is shaped so as to define a distal malecoupling element, e.g., a hexagonal head, that is inserted into acorrespondingly shaped proximal female coupling element, e.g., ahexagonal socket, defined by dental implant 30. Friction between thehead and socket removably couples the implant to the applicator.Alternatively, another coupling element removably couples the implant tothe applicator. A proximal end of applicator 32 is typically shaped soas to define a coupling element 43, such as a female coupling element(as shown in FIG. 1), e.g., a hexagonal or square socket, or a malecoupling element (configuration not shown), e.g., a hexagonal or squarehead. During an implantation procedure, such as described hereinbelowwith reference to FIGS. 25A-J, 26A-B, 27A-E, and 29A-F, the gloved handof the surgeon generally touches the applicator, rather than the implantitself. System 20 is typically packaged and provided to the surgeon withthe applicator 32 coupled to implant 30.

Typically, implant 30 comprises a two-stage implant. The surgeon couplesan abutment to the proximal end of the implant after osseointegration ofthe implant, as is known in the art, such as described hereinbelow withreference to FIG. 25G. Alternatively, implant 30 comprises asingle-stage transgingival implant, which is shaped so as to define anintegrated abutment, as is known in the art.

For some applications, as shown in FIGS. 1A-C (and in FIGS. 3A-D, 15-18,19A-D, 20A-G, 21A-24, and 28A-B hereinbelow), a proximal end of lumen 40has a lateral opening 44 (typically exactly one lateral opening) throughlateral external surface 42 of the implant, and the lumen is not open toa proximal external surface of the implant within 2 mm of aproximal-most part of implant 30. For some applications, the lumen isnot open to the proximal external surface within 3 mm of theproximal-most part of the implant. Implant 30 is typically permanentlyclosed within 3 mm of the proximal-most part of the implant, for theseapplications. Alternatively, the proximal end of lumen 40 is open toproximal implant end 34. Typically, the lateral opening is at least 1.5mm from distal implant end 38, such as at least 2 mm (e.g., 8 mm fromthe distal implant end). Typically, the lateral opening is at least 2 mmfrom the proximal implant end, such as at least 3 mm or at least 4 mm.

System 20 further comprises a delivery tube 50, a distal end of which iscoupled to lumen 40 via lateral opening 44. For some applications, thedistal end of delivery tube 50 is initially welded to implant 30. Thewelding of delivery tube 50 to implant 30 provides a strong seal that isable to withstand the pressure of the fluid provided by fluid source 54(such as described hereinbelow with reference to FIG. 25C) and/or theinjection of a regenerative material (as described hereinbelow withreference to FIG. 25D). The delivery tube may be welded to implant 30 bylaser welding overlapping spots around the circumference of the deliverytube. Alternatively, for some applications, the distal end of deliverytube 50 is initially soldered to implant 30.

For some applications, as best seen in the blow-up in FIG. 1C, a portion72 of the wall of delivery tube 50 is thinner than the wall immediatelyadjacent to the portion, such that application of a breaking torque tothe delivery tube breaks the delivery tube at the thinner portion,thereby decoupling the delivery tube from the implant. Typically, thethinner portion is within 3 mm of the distal end of the delivery tube,such as within 2 mm or within 1 mm of the distal end. The thinnerportion is typically recessed into lateral external surface 42 of theimplant. For some applications, at least a portion of the lateralsurface that includes lateral opening 44 is shaped so as to define screwthread 36. For these applications, the thinner portion is recessed intothe lateral external surface below the raised helical rib of screwthread 36. As a result, the small distal broken portion of the deliverytube that remains coupled to the implant after the delivery tube isbroken does not interfere with the functioning of screw thread 36.

Typically, thinner portion 72 of delivery tube 50 is sufficiently thinsuch that the application of a breaking torque of less than 50 Newtoncentimeters (Ncm) breaks the delivery tube at the thinner portion. Forsome applications, the thinner portion has a width of less than 0.1 mm,such as less than 0.05 mm.

In this application of the present invention (and in some otherapplications of the present invention), delivery tube 50 typicallycomprises a rigid material, such as metal (e.g, titanium). For someapplications, the delivery tube is shaped so as to be circumscribed witha groove 74 that defines thinner portion 72. For example, the tube maybe manufactured by scoring the implant to form the groove that serves asthe thinner portion. Typically, the groove is V-shaped, such thatapplication of the breaking torque causes a concentration of force to beapplied at the tip of the V, thereby breaking the delivery tube at thegroove.

For some applications, the delivery tube is shaped so as to define abend 86 at between about 5 and about 20 mm from the distal tube end,such as within about 10 mm of the distal tube end. For example, the bendmay have an angle of between about 85 and about 95 degrees.

Typically, when delivery tube 50 is coupled to the implant prior tobreaking of thinner portion 72, portion 76 of the delivery tube runsalongside the implant such that, as shown in FIG. 1C, a greatestdistance D between a longitudinal axis 96 of the implant and a surfaceof portion 76 of the delivery tube farthest from the longitudinal axisis less than 7 mm, e.g., less than 6 mm, such as less than 5 mm. Such asmall distance allows the implant and delivery tube to be readily placedbetween adjacent teeth during an implantation procedure, such asdescribed hereinbelow with reference to FIGS. 25B-E.

Alternatively, the delivery tube may be coupled to the lumen using aminiature luer connector, by friction, using a removable couplingelement, and/or as described hereinbelow with reference to FIG. 15-18,19A-D, or 20A-G. Alternatively, the tube may screw into the lumen, so asto be rotationally secured to the implant throughout the implantationprocedure. Further alternatively or additionally, the distal end ofdelivery tube 50 comprises a sealing element, which is configured toremovably sealingly couple delivery tube 50 to implant 30. For example,the sealing element may be configured as shown in and/or describedhereinbelow with reference to FIGS. 19A-B or FIG. 30, or the sealingelement may comprise an o-ring or a gasket.

As shown in FIGS. 1A and 1C, during a portion of an implantationprocedure, a rotation tool 90 is coupled to coupling element 43 of theapplicator 32, for rotating implant 30 via applicator 32. For example,the rotation tool may comprise a conventional manual wrench (e.g., asimple hand wrench, or a ratchet wrench), or a conventional drill ormotor to which an appropriate drill head is attached, and which isoperated at a low speed and at low torque, such as a physiodispenser.Alternatively, rotation tool 90 may comprise a conventional hexagonaltool with a knurled knob, such as a knurled hex screwdriver, and alongits axis, a thin rod having a hexagonal head which fits into a femalehexagonal socket defined by coupling element 43 of applicator 32.

As shown in FIG. 1B, during at least a portion of the implantationprocedure, delivery tube 50 is in fluid communication with a supply tube52, which in turn is in fluid communication with a source of fluid 54.Fluid source 54 may comprise a manual syringe 56 or powered drugdelivery device, as is known in the art. For some applications, aproximal end of supply tube 52 is coupled to fluid source 54, e.g.,manual syringe 56, by a luer lock, which is located remotely fromimplant 30.

Reference is made to FIGS. 2A-C, which are schematic illustrations ofalternative configurations of dental implant 30, in accordance withrespective applications of the present invention. In the configurationshown in FIG. 2A, distal opening 41 of lumen 40 is located on distalimplant end 38 at a location other than a distal tip 70 of the implant.For some applications, the location is within 3 mm of distal tip of 70,as measured along the surface of the distal tip. As mentioned above withreference to FIGS. 1A-C, for some applications, lumen 40 is open to thedistal end via a plurality of distal openings 41, as shown in FIG. 2A.One or more of the openings may be at a location other than distal tip70, including at one or more locations at distal implant end 38 and/orelsewhere on distal implant portion 48. Alternatively, lumen 40 is opento distal implant end 38 or distal implant portion 48 via exactly oneopening (configuration not shown in FIG. 2A).

In the configuration shown in FIG. 2B, distal implant end 38 is concave,such that the raised edge of the concavity defines a sharp cuttingsurface 46. In the configuration shown in FIG. 2C, distal implant end 38is generally flat, and the distal end is shaped so as to define sharpcutting surface 46, typically near the edge of the distal end.

Reference is now made to FIGS. 3A-D, which are schematic illustrationsof alternative configurations of dental implant 30 and applicator 32 inwhich the distal end of delivery tube 50 is initially removably coupledto implant 30 at a first interface to implant 30, in accordance withrespective applications of the present invention. For example, thedelivery tube end may be removably coupled to the implant by beingwelded to the implant at the first interface. FIGS. 3A and 3C showdental implant 30 and applicator 32 not attached to each other, whileFIGS. 3B and 3D show the applicator attached to the dental implant. Forapplications in which the delivery tube end is welded to the implant, aseparate tool is used to break the delivery tube from the implant, suchas one of the tools described hereinbelow with reference to FIG. 4-6B,7-8B, 9A-11D, or 12-14. For some applications, applicator 32 isprovided, in which case the applicator is typically removably coupled tothe proximal end of implant 30, such as using coupling techniquesdescribed hereinabove with reference to FIGS. 1A-C.

In this configuration, delivery tube 50 and applicator 32, if provided,are configured such that the applicator 32 prevents decoupling ofdelivery tube 50 from implant 30, such as by preventing movement (e.g.,rotation) of the delivery tube end with respect to the implant, forexample by preventing application of a breaking torque to the deliverytube, typically by preventing rotation of the distal tube end withrespect to the lateral opening of the implant. For some applications,delivery tube 50 is directly or indirectly removably coupled to implant30 at a second interface remote from the first interface, so as toprevent the movement (e.g., the rotation) of the distal tube end withrespect to the implant. For some applications in which applicator 32 isprovided, the applicator is removably coupled to the proximal implantend at the second interface, and indirectly removably couples thedelivery tube to the implant. For example, delivery tube 50 may comprisea fixing element 100, and applicator 32 may be shaped so as to define acorresponding fixing element receptor 102. When applicator 32 is coupledto implant 30, a proximal portion 104 of fixing element 100 is coupledto fixing element receptor 102, thereby preventing non-longitudinalmovement of the fixing element, and thus rotation of the delivery tube.For example, the fixing element may be oriented generally parallel todistal portion 76 of delivery tube 50 and to longitudinal axis 96 ofimplant 30. Removal of applicator 32 from implant 30 frees the fixingelement, thereby allowing rotation of delivery tube 50 and breakingthereof from the implant.

For some applications, as shown in FIGS. 3A-B, fixing element 100 isshaped so as to define a fixing pin, and fixing element receptor 102 isshaped so as to define a receptor hole. The fixing pin is positionedwithin the fixing hole. For other applications, as shown in FIGS. 3C-D,proximal portion 104 of fixing element 100 is shaped so as to define aslot or groove, and fixing element receptor 102 is shaped so as todefine a corresponding coupling surface that fixes the fixing element tothe fixing element receptor when the applicator is coupled to theimplant. Other pairs of corresponding coupling elements will be evidentto those skilled in the art who have read the present application, andare within the scope of the invention.

Alternatively, for some applications, delivery tube 50 and applicator 32are not configured to prevent decoupling of the delivery tube from theimplant, e.g., the delivery tube does not comprise the fixing pin, andthe applicator is not shaped so as to define the fixing hole.

Reference is now made to FIGS. 4-6B, which are schematic illustrationsof a rotation breaking tool 110, in accordance with an application ofthe present invention.

FIG. 4 is an isometric view of tool 110, FIG. 5A is a side-view of thetool, and FIG. 5B is a cross-sectional side-view of the tool along lineIXB-IXB of FIG. 4. FIGS. 6A-B show tool 110 coupled to implant 30. Tool110 is used to break delivery tube 50 from implant 30, for applicationsin which applicator 32 is not configured to perform such breaking. Forexample, tool 110 may be used with the configuration of implant 30 andapplicator 32 described hereinabove with reference to FIGS. 1A-C and3A-D. Typically, tool 110 is temporarily coupled to the proximal end ofimplant 30 during a surgical procedure, after applicator 32 has beendecoupled from the implant, for example as described hereinbelow withreference to FIG. 25E. (Typically, the tool is coupled to the samecoupling surface of the implant to which the applicator is coupled).Alternatively, tool 110 is coupled to implant 30 indirectly viaapplicator 32, by coupling the tool to the proximal end of theapplicator (configuration not shown).

Tool 110 comprises a handle 112 and a coupling element 114 positionednear a distal end of the handle. For some applications, as shown inFIGS. 4-6B, a longitudinal axis of handle 112 forms an angle of between70 and 90 degrees with a longitudinal axis of coupling element 114,e.g., is perpendicular to coupling element 114, as shown. Couplingelement 114 is configured to temporarily engage a corresponding couplingelement of implant 30. For example, coupling element 114 may comprise amale coupling element that is inserted into a corresponding femalecoupling element of the implant. Friction between coupling element 114and the socket of the implant removably couples the tool to the implant.The male coupling element may, for example, be shaped so as do define ashort cylinder extending from a hexagonal head. Tool 110 furthercomprises a rotating member 116, which is positioned around couplingelement 114, such that a base 117 of the coupling element passes throughthe rotating member, as best seen in FIG. 5B. The rotating member isthus free to rotate with respect to the handle of the tool, while thecoupling element remains stationary with respect to the handle. Rotatingmember 116 is shaped so as to define a human interface surface, in orderto facilitate convenient direct rotation by the surgeon. In theconfigurations described with reference to FIGS. 4-6B, 7-8B, 9A-11D, and12-14, handle 112 typically has a length along a longitudinal axisthereof of at least 2 cm, no more than 12 cm, and/or between 2 and 12cm, e.g., between 4 and 9 cm.

Rotating member 116 comprises a breaking element 118, which extends inthe same direction as coupling element 114 (e.g., perpendicular to thehandle), partially alongside the coupling element. The breaking elementmay, for example, be shaped as a tab. As shown in FIGS. 6A-B, thebreaking element is configured to apply a breaking torque to distalportion 76 of delivery tube 50, upon rotation of rotating member 116.The breaking element typically makes contact with the delivery tube nearbend 86 of the delivery tube. In the exemplary configuration shown inFIGS. 6A-B, rotating member 116 is rotated counterclockwise as viewedfrom above (typically by between 180 and 360 degrees), in order to pushbreaking element 118 against delivery tube 50. The torque rotates thedistal end of the delivery tube with respect to lateral opening 44 ofimplant 30, thereby breaking the delivery tube from the implant. Afterbreaking the delivery tube from the implant, tool 110 is decoupled fromthe implant.

The portion of tool 110 not within implant 30 when the tool is coupledto the implant typically has a height H of between 0.5 and 3 cm, such asless than 2 cm, as shown in FIG. 5B. Such a small height requiresminimal height in the mouth during use of the tool, thereby enablingminimal mouth opening by the patient in order to insert the tool intothe mouth.

Reference is made to FIGS. 7-8B, which are schematic illustrations ofanother configuration of rotation breaking tool 110, in accordance withan application of the present invention. FIG. 7 is a cross-sectionalside-view of tool 110 coupled to implant 30, and FIGS. 8A and 8B showthe tool coupled to implant 30, viewed from the top (the direction inwhich coupling element 114 protrudes), and the side, respectively.

In this configuration of tool 110, as in the configuration shown inFIGS. 4-6B, coupling element 114 typically extends at an angle ofbetween 70 and 90 degrees, e.g., at a right angle. However, unlike inthe configuration shown in FIG. 8-6B, in this configuration the rotatingmember 116 is indirectly, remotely rotated by the surgeon by turning aknob 120 that is typically positioned at or near a proximal end of thehandle. Tool 110 comprises one or more rods, gears, and/or cams (notshown), typically positioned within the handle, which together translatethe rotation of knob 120 to rotation of rotating member 116. As in theconfiguration shown in FIGS. 4-6B, the coupling element remainsstationary with respect to the handle while the rotating member rotates,typically by between 180 and 360 degrees.

Reference is made to FIGS. 9A-B, which are schematic isometric andcross-sectional illustrations, respectively, of yet anotherconfiguration of rotation breaking tool 110, in accordance with anapplication of the present invention. In this configuration of tool 110,unlike in the configurations shown in FIGS. 4-6B and 7-12, couplingelement 114 is oriented at an angle of between 0 and 30 degrees withrespect to a longitudinal axis 122 of handle 112, such as parallel tothe longitudinal axis, typically concentric with the axis. Rotatingmember 116 and breaking element 118 rotate around axis 122.

Tool 110 is configured to enable rotation of breaking element 118 whilecoupling element 114 is held stationary. To enable such rotation, forsome applications handle 112 comprises a rotating sub-handle 124 and astationary sub-handle 126. Rotating sub-handle 124 is in mechanicalcommunication with rotating member 116 via a rotating shaft 128, andstationary sub-handle 126 is in mechanical communication with couplingelement 114 via a stationary shaft 130. For some applications, as shownin FIG. 9A-B, stationary shaft 130 passes through rotating shaft 128.Rotating and stationary sub-handles 124 and 126 typically are shaped soas to define respective knobs, to facilitate easy grasping by thesurgeon. In the configuration shown in FIG. 9A-B, stationary sub-handle126 is proximal to rotating sub-handle 124, i.e., the stationarysub-handle is farther from coupling element 114 than is the rotatingsub-handle.

To use tool 110 to break delivery tube 50 from implant 30, the surgeontemporarily couples coupling element 114 to the proximal end of theimplant. The surgeon holds stationary sub-handle 126 rotationallystationary, while at the same time rotating rotating sub-handle 124(typically by between 180 and 360 degrees). This relative rotationpushes breaking element 118 against delivery tube 50, thereby breakingthe delivery tube from the implant.

Reference is made to FIGS. 10A-B and 11A-D, which are schematicillustrations of components of tool 110 in the configuration shown inFIGS. 9A-B, in accordance with an application of the present invention.FIGS. 10A-B show a first component 132 of tool 110, which componentcomprises stationary sub-handle 126, stationary shaft 130, and couplingelement 114. FIGS. 11A-D show a second component 134 of tool 110, whichcomponent comprises rotating sub-handle 124, rotating shaft 128,rotating member 116, and breaking element 118. Rotating sub-handle 124and rotating shaft 128 together define a lumen 136 that passes throughthe rotating sub-handle and rotating shaft, as shown in FIG. 11B. FIG.11D shows a distal view of the distal end of second component 134.

Tool 110 is assembled by passing stationary shaft 130 of first component132 through lumen 136 of second component 134. First component 132 canfreely rotate with respect to the second component 132. Typically, thecomponents are configured to prevent the first component from separatingfrom the second component.

Reference is made to FIGS. 12-14, which are schematic illustrations ofstill another configuration of rotation breaking tool 110, in accordancewith an application of the present invention. FIGS. 12 and 13 areisometric and cross-sectional views, respectively, of tool 110temporarily coupled to implant 30, and FIG. 14 is an isometricenlargement of a distal end of the tool not coupled to the implant. Inthis configuration of tool 110, as in the configurations shown in FIGS.9A-11D, coupling element 114 is oriented at an angle of between 0 and 30degrees with respect to longitudinal axis 122 of handle 112, such asparallel to the longitudinal axis, typically concentric with the axis.Rotating member 116 and breaking element 118 rotate around axis 122.

Tool 110 is configured to enable rotation of breaking element 118 whilecoupling element 114 is held stationary. To enable such rotation, forsome applications tool 110 comprises rotating sub-handle 124 andstationary sub-handle 126. Rotating sub-handle 124 is in mechanicalcommunication with rotating member 116 via rotating shaft 128, andstationary sub-handle 126 is in mechanical communication with couplingelement 114 via stationary shaft 130. For some applications, as shown inFIGS. 12 and 13, rotating shaft 128 passes through stationary shaft 130(unlike the configuration shown in FIGS. 9A-11D, in which stationaryshaft 130 passes through rotating shaft 128). Rotating shaft 128 is inmechanical communication with rotating member 116 via a connectingelement 140 that passes through stationary shaft 130, as shown in FIG.13. Rotating and stationary sub-handles 124 and 126 typically are shapedso as to define respective knobs, to facilitate easy grasping by thesurgeon. In the configuration shown in FIG. 12-14, unlike in theconfiguration shown in FIGS. 9A-11D, rotating sub-handle 124 is proximalto stationary sub-handle 126, i.e., the rotating sub-handle is fartherfrom coupling element 114 than is the stationary sub-handle.

To use tool 110 to break delivery tube 50 from implant 30, the surgeontemporarily couples coupling element 114 to the proximal end of theimplant. The surgeon holds stationary sub-handle 126 rotationallystationary, while at the same time rotating rotating sub-handle 124(typically by between 180 and 360 degrees). This relative rotationpushes breaking element 118 against delivery tube 50, thereby breakingthe delivery tube from the implant.

Rotation breaking tool 110, as described hereinabove with reference toFIGS. 4-6B, 7-8B, 9A-11D, and 12-14, is configured to stabilize implant30 during the breaking of delivery tube 50 from the implant. Duringbreaking, the surgeon holds handle 112 stable, which in turn holdscoupling element 114 of tool 110 stable, and thereby stabilizes theimplant to which the coupling element is coupled. Rotating member 116,when rotated, applies stress only between breaking element 118 anddelivery tube 50.

In some applications of the present invention in which delivery tube 50is initially coupled to implant 30 (such as by welding), the human handof the surgeon grasps the delivery tube and applies the breaking torqueto the delivery tube to decouple the distal tube end from the implant.Alternatively or additionally, the breaking torque is applied using atool that is brought into contact with the delivery tube. Optionally,the tool may be configured to grasp the delivery tube; for example, thetool may comprise a needle holder, forceps, or tweezers.

Reference is made to FIGS. 15, 16, 17A-E, and 18, which are schematicillustrations of dental implant 30 and applicator 32 comprising aretaining element 170, in accordance with an application of the presentinvention. FIG. 15 and FIG. 16 (a cross-section view of FIG. 15) showretaining element 170 in a first position in which the retaining elementprevents the distal end of delivery tube 50 from separating from implant30. Retaining element 170 thus holds the distal end of delivery tube 50sealingly coupled to implant 30 such that the delivery tube is in fluidcommunication with lumen 40 of implant 30 via lateral opening 44 ofimplant 30. In this application, delivery tube 50 is not welded toimplant 30. Retaining element nevertheless 170 provides a strong sealthat is able to withstand the pressure of the fluid provided by fluidsource 54 and the injection of a regenerative material, if performed. Ascan be seen in FIGS. 15 and 16, at least a portion of retaining element170 is disposed remotely from lateral opening 44 when the retainingelement is in the first position, e.g., at least 1 cm, such as 1.5 cm or2 cm from lateral opening 44 when the retaining element is in the firstposition. Typically, at least a portion of (e.g., all of) retainingelement 170 comprises one or more rigid materials, such as metal and/orplastic.

FIGS. 17A-E are views from respective directions in which retainingelement 170 assumes a second position in which the retaining elementdoes not prevent the distal tube end from separating from the implant,such that delivery tube 50 becomes decoupled from the implant. FIG. 18is a cross-sectional view of FIG. 17A.

In this configuration, retaining element 170 is typically an integralpart of applicator 32, e.g., applicator 32 is fixed to retaining element170, and delivery tube 50 is coupled to retaining element 170. Implant30 is typically packaged and provided to the surgeon pre-coupled toapplicator 32, with the retaining element in the first position in whichit prevents the distal end of the delivery tube from separating from theimplant. The implant, applicator, and retaining element are configuredsuch that the coupling of the applicator to the implant provides properrotational orientation to precisely align the distal end of deliverytube 50 with lateral opening 44. After the dental implant has beenscrewed into the ridge, and fluid and/or regenerative material has beeninjected through delivery tube 50 and implant 30, the surgeon causes theretaining element to assume the second position, thereby decoupling thedelivery tube from the implant.

Applicator 32 is typically removably coupled to the proximal end ofimplant 30, such as using coupling techniques described hereinabove withreference to FIGS. 1A-C. A proximal end of applicator 32 is typicallyshaped so as to define a coupling element, such as a male couplingelement (as shown in FIGS. 15-18), e.g., a hexagonal head, or a femalecoupling element (configuration not shown), e.g., a hexagonal socket.Implant 30 may comprise a two-stage implant, or a single-stagetransgingival implant, both of which are described hereinabove withreference to FIGS. 1A-C.

For some applications, the distal end of delivery tube 50 is shaped soas to define a cone. For example, as shown in FIG. 16, the cone may havean opening angle θ (theta) of between 0 and 90 degrees, such as betweenabout 0 and about 60 degrees. For some applications, the cone forms aMorse taper, in which case the distal end of delivery tube 50 must beremoved with force when retaining element 170 assumes the secondposition.

For some applications, retaining element 170 comprises a retainingelement body 172, a pivoting element 174, and a proximal blockingelement 176. Delivery tube 50 is coupled to the pivoting element. Thepivoting element is configured to pivot with respect to the retainingelement body, such that the delivery tube also pivots with respect tothe retaining element body, and thereby with respect to applicator 32.

Blocking element 176 can be advanced distally and withdrawn proximallywithin applicator 32, such as by rotating the blocking element. When ina distal position, the blocking element prevents pivoting element 174from pivoting freely, thereby causing retaining element 170 to assumethe first position in which the retaining element prevents the distalend of delivery tube 50 from separating from implant 30. When in aproximal position, the blocking element does not interfere with thepivoting of pivoting element 174, thereby allowing retaining element 170to assume the second position in which the retaining element does notprevent the distal end of delivery tube 50 from separating from implant30.

For some applications, as shown in FIGS. 17D-E, applicator 32 furthercomprises a spring 178, which is configured to apply a force thatseparates the distal tube end from the implant when the retainingelement assumes the second position.

For some applications, the distal end of delivery tube 50 comprises asealing element, which is configured to removably sealingly coupledelivery tube 50 to lateral opening 44 of implant 30. For example, thesealing element may be configured as shown in and/or describedhereinbelow with reference to FIGS. 19A-B or FIG. 30, or the sealingelement may comprise an o-ring or a gasket.

Reference is now made to FIGS. 19A-D, which are schematic illustrationsof another configuration of dental implant 30, applicator 32, andretaining element 170, in accordance with an application of the presentinvention. FIGS. 19A-B and 19C are isometric and cross-sectional views,respectively, showing retaining element 170 in a second position(similar to the second position described hereinabove with reference toFIGS. 17A-E), in which the distal end of delivery tube 50 is not coupledto implant 30. FIG. 19D is a cross-sectional view showing retainingelement 170 in a first position (similar to the first position describedhereinabove with reference to FIGS. 15 and 16), in which the retainingelement holds the distal end of the delivery tube sealingly coupled toimplant 30 such that the delivery tube is in fluid communication withlumen 40 of the implant 30 via lateral opening 44 of implant 30. As canbe seen in FIG. 19D, at least a portion of retaining element 170 isdisposed remotely from lateral opening 44 when the retaining element isin the first position, e.g., at least 1 cm, such as 1.5 cm or 2 cm fromlateral opening 44 when the retaining element is in the first position.Typically, at least a portion of (e.g., all of) retaining element 170comprises one or more rigid materials, such as metal and/or plastic.

Applicator 32 is typically removably coupled to the proximal end ofimplant 30, such as using the coupling techniques described hereinabovewith reference to FIGS. 1A-C. A proximal end of applicator 32 istypically shaped so as to define a coupling element, such as a malecoupling element (as shown in FIGS. 19A-D), e.g., a hexagonal head, or afemale coupling element (configuration not shown), e.g., a hexagonalsocket. Implant 30 may comprise a two-stage implant, or a single-stagetransgingival implant, both of which are described hereinabove withreference to FIGS. 1A-C.

In this application, delivery tube 50 is not welded to implant 30.Retaining element nevertheless 170 provides a strong seal that is ableto withstand the pressure of the fluid provided by fluid source 54 (asdescribed hereinbelow with reference to FIG. 26B) and the subsequentinjection of a regenerative material, if performed.

In this configuration, retaining element 170 and applicator 32 aretypically provided as separate components of dental implant system 20,that are removably coupled to each other by the surgeon during a dentalprocedure. Delivery tube 50 is coupled to retaining element 170. Implant30 is typically packaged and provided to the surgeon pre-coupled toapplicator 32, while retaining element 170 is provided separately, notcoupled to the applicator or implant. Alternatively, the surgeon couplesapplicator 32 to implant 30 during the implantation procedure. After thedental implant has been screwed into the ridge, such as describedhereinbelow with reference to FIG. 26A, the surgeon attaches retainingelement 170 to applicator 32, with the retaining element in the secondposition, such as described hereinbelow with reference to FIG. 26B. Thesurgeon then causes the retaining element to assume the first position,thereby coupling the delivery tube to the implant. The implant,applicator, and retaining element are configured such that the couplingof the applicator to the implant provides proper rotational andlongitudinal orientation to precisely align the distal end of deliverytube 50 with lateral opening 44.

The surgeon injects fluid and/or regenerative material through deliverytube 50 and implant 30. The surgeon decouples the delivery tube from theimplant, removes the retaining element from the applicator, and thenremoves the applicator from the implant.

For some applications, retaining element 170 comprises retaining elementbody 172, a portion of which is configured to be disposed alongsideimplant 30 from applicator 32 to lateral opening 44 of implant 30.Optionally, the proximal end of applicator 32 slightly protrudesproximally from retaining element body 172, as shown in FIGS. 19A-D. Forsome applications, retaining element 170 further comprises a shaft 180,a first end of which serves as the distal end of delivery tube 50, andis shaped so as to provide a coupling port 184 for delivery tube 50. Theshaft is configured to sealingly couple the coupling port to lateralopening 44 of implant 30. To this end, the coupling port 184 (i.e., thedistal end of delivery tube 50) typically comprises a sealing element186. For example, the sealing element may be configured as describedhereinbelow with reference to FIG. 30, or the sealing element maycomprise an o-ring or a gasket. The shaft is typically oriented suchthat a longitudinal axis thereof forms an angle of 90 degrees with thelongitudinal axis of the implant, e.g., 90 degrees. As is shown in FIGS.19A-D, when retaining element 170 is in the first and the secondpositions, shaft 180 and the distal end of delivery tube 50 arepositioned at a same circumferential side of implant 30 (e.g., the leftside in FIG. 19A, and the right side in FIGS. 19C-D).

For some applications, shaft 180 is configured such that rotation of aportion thereof brings coupling port 184 (and the distal tube end) intocontact with lateral opening 44 of implant 30. For example, an externalsurface of a portion of shaft 180 may be shaped so as to define a screwthread 188, which passes through a lumen of retaining element body 172that is shaped so as to define a corresponding screw thread. The end ofshaft 180 opposite the end that provides coupling port 184 is typicallyshaped so as to define a knob 190, for facilitating rotation of theshaft 180 by the surgeon.

For some applications, implant 30 comprises a removable plug that isconfigured to seal lateral opening 44. The plug is removed beforeretaining element 170 is applied to couple the distal end of deliverytube 50 to implant 30.

For some applications, the distal end of delivery tube 50 is shaped soas to define a cone, such as described hereinabove with reference toFIG. 16. For example, the cone may have an opening angle of between 0and 90 degrees, such as between 0 and 60 degrees.

For some applications, retaining element 170 is configured to be coupleddirectly to dental implant 30, rather than to applicator 32. For theseapplications, retaining element 170 is typically removably coupled tothe proximal end of implant 30, such as using the coupling techniquesfor coupling applicator 32 to implant 30, described hereinabove withreference to FIGS. 1A-C, mutatis mutandis. A surface of retainingelement 170 is typically shaped so as to define a coupling element, suchas a male coupling element, e.g., a hexagonal head, or a female couplingelement, e.g., a hexagonal socket. For example, retaining element 170may comprise and be fixed to the component that is shown as applicator32 in FIG. 19A-D.

For these applications, applicator 32 still may be provided for use inone or more steps of an implantation procedure before the retainingelement is coupled to the dental implant (but not for coupling theretaining element to the implant). For example, applicator 32 may beused for the step of the implantation procedure described hereinbelowwith reference to FIG. 26A. The applicator is decoupled from the implantbefore coupling the retaining element to the dental implant, forperforming the step of the procedure described hereinbelow withreference to FIG. 26B.

Reference is now made to FIGS. 20A-G, which are schematic illustrationsof yet another configuration of dental implant 30, applicator 32, andretaining element 170, in accordance with an application of the presentinvention. FIGS. 20A-B and 20E-F are isometric views showing retainingelement 170 in a second position (similar to the second positiondescribed hereinabove with reference to FIGS. 17A-E and FIGS. 19A-B and19C), in which the distal end of delivery tube 50 is not coupled toimplant 30. FIGS. 20C-D are isometric views showing retaining element170 in a first position (similar to the first position describedhereinabove with reference to FIGS. 15 and 16 and FIG. 19D), in whichthe retaining element holds the distal end of the delivery tubesealingly coupled to implant 30 such that the delivery tube is in fluidcommunication with lumen 40 of the implant 30 via lateral opening 44 ofimplant 30. Another view of this configuration of retaining element 170is provided in FIG. 30, which is described hereinbelow. As can be seenin FIGS. 20C-D, at least a portion of retaining element 170 is disposedremotely from lateral opening 44 when the retaining element is in thefirst position. For example, at least a portion of retaining element 170may be disposed at least 1 cm, such as 1.5 cm or 2 cm from lateralopening 44 when the retaining element is in the first position.Typically, at least a portion of (e.g., all of) retaining element 170comprises one or more rigid materials, such as metal or plastic.

Except as described hereinbelow, this configuration of dental implant30, applicator 32, and retaining element 170 is generally similar to,and may incorporate any of the features of, the configuration describedhereinabove with reference to FIGS. 19A-D. For some applications, aproximal end of delivery tube 50 is coupled to a fluid source, e.g.,fluid source 54, such as manual syringe 56 (described hereinabove withreference to FIG. 1B), by a luer lock, which is located remotely fromimplant 30. A luer lock may also be used to couple the distal end of thedelivery tube to a fluid source in the other configurations describedherein, including, but limited to, the configuration described withreference to FIGS. 19A-D.

In this configuration, retaining element 170 and applicator 32 aretypically provided as separate components of dental implant system 20,that are removably coupled to each other by the surgeon during a dentalprocedure. Delivery tube 50 is coupled to retaining element 170. Implant30 is typically packaged and provided to the surgeon pre-coupled toapplicator 32, while retaining element 170 is provided separately, notcoupled to the applicator or implant. Alternatively, the surgeon couplesapplicator 32 to implant 30 during the implantation procedure. After thedental implant has been screwed into the ridge, such as describedhereinbelow with reference to FIG. 26A, the surgeon attaches retainingelement 170 to applicator 32, with the retaining element in the secondposition, as shown in FIG. 20B, and such as described hereinbelow withreference to FIG. 26B. The surgeon then causes the retaining element toassume the first position, thereby coupling the delivery tube to theimplant, as shown in FIG. 20C. The implant, applicator, and retainingelement are configured such that the coupling of the applicator to theimplant provides proper rotational and longitudinal orientation toprecisely align the distal end of delivery tube 50 with lateral opening44.

The surgeon injects fluid and/or regenerative material through deliverytube 50 and implant 30. The surgeon decouples the delivery tube from theimplant, removes the retaining element from the applicator, as shown inFIGS. 20D-F. The surgeon then decouples the applicator from the implant,as shown in FIG. 20G. For example, the surgeon may decoupled connectingelement 98 from the applicator and the implant, such as describedhereinbelow with reference to FIGS. 21A-D, 22A-B, 23, and 24.

For some applications, retaining element 170 comprises retaining elementbody 172, a portion of which is configured to be disposed alongsideimplant 30 from applicator 32 to lateral opening 44 of implant 30.Optionally, the proximal end of applicator 32 slightly protrudesproximally from retaining element body 172, as shown in FIGS. 20A-G.

For some applications, retaining element 170 further comprises a shaft182. The shaft is configured to couple retaining element 170 to implant30, such that the distal end of delivery tube 50 is removably sealinglycoupled to lateral opening 44 of implant 30. To this end, the distal endof delivery tube 50 typically comprises a sealing element 187. For someapplications, sealing element 187 is configured as described hereinbelowwith reference to FIG. 30. Alternatively, the sealing element maycomprise an o-ring or a gasket. The shaft is typically oriented suchthat a longitudinal axis thereof forms an angle of 90 degrees with thelongitudinal axis of the implant, e.g., 90 degrees.

For some applications, retaining element 170 is configured such thatwhen the retaining element is in the first position (coupled to implant30), shaft 182 and the distal end of delivery tube 50 are positioned atcircumferentially opposite sides of implant 30, albeit typically atdifferent longitudinal positions along the implant (the shaft istypically positioned longitudinally proximal to the delivery tube end).For some applications, during an implantation procedure, shaft 182 (andknob 190) are positioned at the palatal aspect of the ridge.

For some applications, shaft 182 is configured such that rotationthereof in a first direction, as symbolically indicated by a clockwisearrow 183 in FIG. 20C, transitions the retaining element from the second(uncoupled) position to the first (coupled) position, thereby couplingthe retaining element to the implant, and bringing the distal tube endinto contact with lateral opening 44 of implant 30, as shown in FIG.20C. Rotation of the shaft in a second direction opposite the firstdirection, as symbolically indicated by a clockwise arrow 185 in FIG.20D, transitions the retaining element from the first position to thesecond position, thereby decoupling the retaining element from theimplant. For example, an external surface of a portion of shaft 182 maybe shaped so as to define screw thread 188, which passes through a lumenof retaining element body 172 that is shaped so as to define acorresponding screw thread. The end of shaft 182 near the implant pushesagainst a lateral surface of the applicator (as shown) or of the implant(configuration not shown), thereby drawing the distal tube end, which isdisposed on the opposite side of the retaining element, toward opening44. The end of shaft 182 away from the implant is typically shaped so asto define knob 190, for facilitating rotation of the shaft 182 by thesurgeon.

Reference is made to FIGS. 21A-D, 22A-B, 23, and 24, which are schematicillustrations of dental implant 30 and applicator 32 in which the distalend of delivery tube 50 is initially welded to implant 30, in accordancewith an application of the present invention. In this configuration ofsystem 20, applicator 32 is configured to break delivery tube 50 fromthe implant. FIGS. 21A-D are views from respective directions of theimplant and applicator in which delivery tube 50 is coupled to theimplant, such that the delivery tube is in fluid communication withlumen 40 of implant 30 via lateral opening 44 of implant 30. FIGS. 22A-Bare cross-sectional views taken along lines IVA-IVA and IVB-IVB of FIG.21A, respectively. FIG. 23 shows the implant and applicator after thedelivery tube has been broken, as described hereinbelow, and FIG. 24 isa cross-sectional view of FIG. 23.

Applicator 32 is typically removably coupled to the proximal end ofimplant 30, such as using coupling techniques described hereinabove withreference to FIGS. 1A-C. A proximal end of applicator 32 is typicallyshaped so as to define a coupling element, such as a male couplingelement (as shown in FIGS. 3A-6), e.g., a hexagonal head, or a femalecoupling element (configuration not shown), e.g., a hexagonal socket.Implant 30 may comprise a two-stage implant, or a single-stagetransgingival implant, both of which are described hereinabove withreference to FIGS. 1A-C.

For some applications, applicator 32 is configured to break deliverytube 50 at thinner portion 72 by rotating the distal end of the deliverytube with respect to lateral opening 44 of the implant. Typically,applicator 32 is configured to apply a torque of greater than 50 Newtoncentimeters to the delivery tube, when rotating the distal tube end withrespect to the lateral opening. The applicator typically applies thetorque to the delivery tube without applying any meaningful torque tothe implant itself, and thus does not dislodge or misalign the implant,which has been precisely placed in a bore in the ridge. For someapplications, a distal portion 76 of delivery tube 50 is initiallypositioned generally parallel to central longitudinal axis 96 of implant30 before thinner portion 72 is broken, as shown in FIGS. 21A-D and22A-B. Applicator 32 rotates the distal end of the delivery tube byrotating portion 76 between about 5 and about 20 degrees, e.g., about 10degrees, until thinner portion 72 breaks, as shown in FIGS. 5 and 6.

For some applications, applicator 32 comprises a lever arm 78, which iscoupled to delivery tube 50 and arrange to rotate the distal tube endwith respect to lateral opening 44. For some applications, the deliverytube is shaped so as to define bend 86 at between about 5 and about 20mm from the distal tube end, and lever arm 78 is coupled to the deliverytube at a location proximal to the bend. For these applications, thebend typically has an angle of between 85 and 180 degrees. For someapplications, applicator 32 comprises a rotatable surface 92 accessiblefrom a proximal end of the applicator, which rotatable surface isrotatable with respect to a portion of the applicator. Rotation ofrotatable surface 92 rotates the distal tube end by extending lever arm78. For example, rotation of the rotatable surface may distally advancea transfer element 94 that extends the lever arm. For example, rotatablesurface 92 may define an internal hex, e.g., having an internal width ofabout 2.4 mm (the hex width is the distance between parallel sides ofthe hexagon).

For some applications, applicator 32 comprises a connecting element 98,which removably couples the applicator to the proximal implant end. Forsome applications, the connecting element comprises a connecting screw;for example, the connecting element may comprise a shaft, at least aportion of which defines a screw thread. Typically, the head ofconnecting element 98 is accessible from a channel than passes throughrotatable surface 92, such that the head can be rotated with ascrewdriver tool inserted through the proximal end of the applicator, inorder to decouple the applicator from the implant. For example, theconnecting screw may define an internal hex that has an internal widthless than that of rotatable surface 92, e.g., about 1.25 mm. For someapplications, the applicator is configured such that rotation ofrotatable surface 92 both (a) applies the breaking torque to thedelivery tube that breaks the delivery tube at the thinner portion, and(b) rotates connecting element 98 to decouple the applicator from theproximal implant end.

For other applications, the connecting element does not comprise ascrew, and instead comprises one or more surfaces, such as conicalsurfaces, that are configured to removably couple the applicator to theproximal implant end by friction. For example, the applicator maycomprise a male coupling element, that is configured to be coupled to afemale coupling element of the implant.

Reference is made to FIGS. 25A-G, which are schematic illustrations ofseveral steps of a minimally-invasive closed sinus lift surgicalprocedure for implanting dental implant 30, in accordance with anapplication of the present invention. The procedure is typicallyemployed when a patient's maxillary alveolar ridge lacks sufficient bonemass to support a conventional dental implant. The procedure isparticularly appropriate for implanting the configuration of implant 30described hereinabove with reference to FIGS. 1A-C, optionally incombination with one or more of the features described hereinabove withreference to FIGS. 2A-C, 3A-B, 3C-D, and/or 28A-B.

A surgeon begins the procedure by preparing the oral facial region, andadministering a local anesthetic. Optionally, as shown in FIG. 25A, thesurgeon initiates an osteotomy in a maxillary alveolar ridge 200 bymaking a preliminary portion of a bore using a dental drill, such as aconventional sinus bur 202. This preliminary bore portion typically hasa diameter of between about 1 and about 7 mm, e.g., between about 2 andabout 6 mm, and leaves residual bone thickness of between about 0.5 andabout 5 mm, e.g., between about 1 and about 4 mm, or between about 0.5and about 2 mm, e.g., between about 1 and about 2 mm. Optionally, thesurgeon widens the bore using a series of successively wider drill bits,until a desired bore diameters is achieved (for example, the largestdrill bit may have a diameter of 3.65 mm for an implant having adiameter of 4.2 mm, or a diameter of 4.2 mm for an implant having adiameter of 5 mm). The bore may be measured using techniques known inthe art, such as CT, x-ray, or x-ray with a depth guide. For someapplications, a surgical guide is used to ensure clearance between thecenter of the osteotomy and the nearest tooth surfaces. Optionally, apre-surgery radiograph (e.g., CT or x-ray) is performed, in order toenable the surgeon to estimate the height of the residual bone and planthe osteotomy accordingly.

For some applications, the surgeon uses a surgery guidance system forensuring that the osteotomy is drilled to the requisite depth. Forexample, the surgeon may use Nobel Guide™ (Nobel Biocare, Zurich,Switzerland) or Simplant® dental software (Materialise Dental NV,Leuven, Belgium). These techniques use a combination of computerizedmodels with physical surgical guiding devices to allow the dentist todrill an osteotomy at the requisite location, angulation, and depth.

After drilling the preliminary bore portion, the surgeon advances dentalimplant 30 into the bore by screwing the implant into ridge 200 usingsurgical rotation tool 90 (described hereinabove with reference to FIGS.1A and 1C), as shown in FIG. 25B. The surgeon typically screws theimplant until distal implant end 38 reaches the end of the osteotomy.The surgeon then advances the implant slightly (typically, by about oneadditional rotation), causing the implant to break through the top ofridge 200 to below a Schneiderian membrane 222, thereby bringing distalopening(s) 41 into fluid communication with a surface of the membranefacing ridge 200, as shown in FIG. 25B. Distal implant end 38 typicallydoes not pass through the top of ridge 200, at least at this stage inthe procedure.

Optionally, after the initial insertion of the implant into the bore,the surgeon uses a periapical radiograph to estimate remaining distancefrom implant tip to the sinus floor. The surgeon rotates the implant topenetrate into the sinus, such as by rotating the implant by a number ofrotations equal to the remaining distance divided by a constant, e.g.,1.2 mm. Optionally, the surgeon performs an additional periapicalradiograph to ensure that the implant has penetrated into the sinuscavity.

After the implant has been advanced to membrane 222, the surgeondecouples rotation tool 90 from applicator 32, and couples supply tube52 to the proximal end of delivery tube 50, as shown in FIG. 25C. Thesurgeon gently lifts and separates membrane 222 from the top of ridge200 into a maxillary sinus 228, by injecting a fluid 229, such as abiocompatible solution such as normal saline solution or a gas, fromfluid source 54 (optionally, under controlled pressure) via supply tube52, delivery tube 50, and lumen 40, so as to form a cavity 220 under themembrane between the ridge and the membrane (in FIG. 25C, the membraneis shown partially raised). Typically, the surgeon injects sufficientfluid 229 into cavity 220 to inflate the cavity to a vertical height ofbetween about 2 and about 20 mm from the top of ridge 200, such asbetween about 2 and about 11 mm, e.g., between about 2 and about 8 mm.For some applications, a measured volume of fluid 229 is injected inorder to achieve the desired cavity height, such as between about 0.5and about 6 ml of fluid, e.g., between about 1 and about 4 ml, betweenabout 1 and about 3 ml, or between about 2 and about 4 ml.

For some applications, the fluid is drained from the cavity. For someapplications, the surgeon detects that membrane 222 has detached fromthe top of ridge 200 by observing blood within the drained fluid 229.The membrane bleeds as it detaches because of the hydraulic pressure offluid 229. Blood flows into the fluid and may be observed in supply tube52 and/or fluid source 54, e.g., syringe 56. The presence of this bloodserves as positive indication that the distal end of the implant hasreached the sinus and the membrane has separate from the ridge. If bloodis not seen, the surgeon may inject additional fluid and/or advance theimplant farther into the ridge. Optionally, the surgeon may instruct thepatient to sit up as well, to enhance the return of fluid from thecavity.

For some applications, after draining the fluid from the cavity, thesurgeon injects a regenerative material 230, such as liquid or gel bonegraft, into cavity 220, as shown in FIG. 25D. Fluid source 54 or aseparate syringe or powered drug delivery device is used for injectingthe regenerative material. If a separate syringe or device is used toinject the material, the material may be provided via supply tube 52, orvia a separate supply tube coupled to the proximal end of delivery tube50. Regenerative material 230 may comprise an allograph, an autogeneousbone graft, or a xenograft, and may, for example, comprise a naturalmaterial, a synthetic material, or a mixture thereof. For example,regenerative material 230 may comprise one of the following commerciallyavailable fluid bone graft materials: DBX Paste (MTF), Allomatrix(Wright), Cerament (Bone Support), DynaGraft (Citagenix/ISOTIS),Fisiograft (Ghimas), Grafton (Osteotech), Optium DBM Gel (Lifenet/DepuyJ&J), OsteoMax (Orthfix), PD VitalOs Cemen (VitalOs), or Regenafil®(Exactech). Alternatively, regenerative material 230 may comprise thecomposition described hereinbelow that comprises saline solution mixedwith solid bone graft particles. Optionally, the system monitors andgenerates an output indicative of the pressure of the regenerativematerial as it is injected.

For some applications, system 20 measures the volume of fluid 229injected into the cavity between the ridge and the membrane whileforming cavity 220, at the step of the procedure described hereinabovewith reference to FIG. 25C. Responsively to the measured volume, thesurgeon determines an amount of regenerative material 230 to inject intocavity 220 at the step of the procedure described hereinabove withreference to FIG. 25D. Typically, the amount of regenerative material230 is approximately equal to the volume of injected fluid 229, orslightly greater or less than the volume of the injected fluid. As aresult, waste of regenerative material 230 is generally minimized, andthe likelihood of perforating the membrane by injection of theregenerative material is generally reduced.

For some applications, the surgeon uses a flexible wire as a piston tohelp push the regenerative material through the supply tube and/orlumen. This technique may be helpful when the regenerative material isviscous and thus difficult to inject using an ordinary syringe.

Alternatively, for some applications, regenerative material 230 is notinjected into the cavity, i.e., the step of the procedure describedhereinabove with reference to FIG. 25D is omitted. Fluid 229, which maycomprise saline solution, is left in cavity 220, or, alternatively, isdrained from the cavity. Recent research has shown that elevation of theSchneiderian membrane and subsequent support thereof in a tentedposition promotes new bone formation even without the introduction ofbone regenerative material (for example, see the above-mentioned articleby Pjetursson et al., which is incorporated herein by reference). Iffluid 229 is left in place in the cavity, the fluid holds the membranein the raised position. If the fluid is drained, implant 30, whenadvanced as described hereinbelow with reference to FIG. 25F, holds themembrane in the raised position.

Further alternatively, at the step described hereinabove with referenceto FIG. 25D, instead of injecting regenerative material 230, the surgeoninjects an alternative therapeutic material, such as one or a mixture ofmore than one of the following materials: a bone growth stimulatingsubstance, such as a bone morphogenetic protein (BMP), and blood.

Still further alternatively, the surgeon injects regenerative material230, rather than fluid 229, to lift membrane 222, thereby combining thesteps of the procedure described hereinabove with reference to FIGS. 25Cand 25D. In this case, the regenerative material typically comprises aliquid.

As shown in FIG. 25E, the surgeon breaks delivery tube 50 from implant30, for example using one of the tools described hereinabove withreference to FIG. 4-6B, 7-8B, 9A-11D, or 12-14. Before coupling the toolto the implant, the surgeon decouples applicator 32 from the implant,for example using a driver tool, e.g., similar to driver 262 describedhereinbelow with reference to FIG. 27C. (For applications in whichimplant 30 implements the techniques described hereinabove withreference to FIG. 3A-B or 3C-D, such decoupling additionally allowsrotation of delivery tube 50 and breaking thereof from the implant).Optionally, the surgeon is provided with more than one of these tools,and selects the tool that is most convenient to use based on thelocation of the implant in the patient's oral cavity, and the particularcharacteristics of the patient and the surgical procedure. The surgeonmay break delivery tube 50 from implant 30 before or after decouplingsupply tube 52 from the proximal end of delivery tube 50, as decided bythe surgeon based on surgical conditions. After breaking the deliverytube from the implant, the surgeon decouples the tool from the implant.

After decoupling delivery tube 50 from implant 30, the surgeon furtheradvances (e.g., by rotating or screwing) implant 30 into regenerativematerial 230 in cavity 220, as shown in FIG. 25F. For example, thesurgeon may use the same surgical rotation tool 90 described hereinabovewith reference to FIG. 25B, by coupling the rotation tool to theproximal coupling element defined by implant 30. This additionaladvancing of the implant advances lateral surface 42 of implant 30 atleast until lateral opening 44 is positioned entirely within the bore inridge 200 and/or in regenerative material 230 in cavity 220. Suchpositioning of both ends of lumen 40 within bone substantially reducesthe risk of infection, because proximal end 34 of implant 30 that isexposed to the oral cavity or gingiva is permanently closed. Typically,the surgeon couples a cover screw to the proximal end of the implantusing a hand driver, and sutures the gingiva.

For some applications, after decoupling delivery tube 50 from implant 30and before further advancing the implant, the surgeon plugs lateralopening 44 of implant 30, using a plug (configuration not shown). Theplug may be configured to be (a) screwed in, (b) pushed in by frictionor a Morse taper, and/or (c) glued in using a cement or adhesive.Alternatively or additionally, the plug may comprise a cement oradhesive material that solidifies in opening 44. Optionally, the outersurface of the plug is treated using known techniques for implantsurface treatment to enhance osseointegration.

As shown in FIG. 25G, after bone grows in cavity 220 (into regenerativematerial 230, if injected) and is integrated into ridge 200, anappliance 140, such as a crown, is coupled to implant 30, typicallyusing an abutment 242 coupled to implant 30, as is known in the art.Alternatively, as mentioned above, implant 30 comprises a single-stagetransgingival implant/abutment, as is known in the art.

Reference is made to FIGS. 25H-J, which are schematic cross-sectionalillustrations of alternative techniques for injecting regenerativematerial 230, taken along line XXVH-XXVH of FIG. 25D, in accordance withrespective applications of the present invention. These techniques areused instead of or in addition to the injection technique describedhereinabove with reference to FIG. 25D. In these techniques, aftermembrane 222 has been lifted from the top of ridge 200, as describedhereinabove with reference to FIG. 25C, the surgeon forms a second borethrough the ridge at a second bore location, e.g., using a dental drill.The second bore location is typically at least 1 mm, such as at least 2mm or at least 3 mm, from a first bore location of the bore describedhereinabove with reference to FIG. 25C. The surgeon injects regenerativematerial 230 into cavity 220, typically using a separate syringe 246 orpowered drug delivery device, via a supply line 248.

For some applications, as shown in FIGS. 25H and 25I, the surgeoninjects the regenerative material by inserting an adaptor 243 into thesecond bore. The adaptor is shaped so as to define a channeltherethrough. Supply line 248 is coupled to the proximal end of thechannel. For example, adaptor 243 may be threaded, as shown in FIG. 25H,in which case the surgeon screws the adaptor into the second bore. Inthis configuration, adaptor 243 is typically rigid, and may comprise ametal. Alternatively, the adaptor may not be threaded, as shown in FIG.25I, in which case the surgeon presses the adaptor into the second bore.In this configuration, the adaptor may be rigid (e.g., may comprise ametal) or flexible (e.g., may comprise rubber). Optionally, the adaptoris conical.

For other applications, the surgeon injects the regenerative materialusing a needle 244, as shown in FIG. 25J. The surgeon may form thesecond bore using a dental drill, or form the second bore directly usingthe needle. For still other applications, the surgeon injects thematerial through a channel of a drill bit.

Insertion of the regenerative material through a separate bore allowsthe use of an implant having a narrower lumen 40 and/or delivery tube50, because the lumen and delivery tube need only allow passage of thefluid as described hereinabove with reference to FIG. 25C, and not theregenerative material, which is generally more viscous than the fluid.

For some applications, the sinus lift is performed using a conventionalsurgical drill with irrigation, such as internal irrigation, as is knownin the art and commercially available. The regenerative material isinjected through a second bore, as described hereinabove with referenceto FIGS. 25H-J. In addition to allowing the use of a narrower lumenthrough the drill bit, insertion of the regenerative material through aseparate bore allows the use of a narrower drill bit for performing thesinus lift through the first bore.

Reference is made to FIGS. 26A-B, which are schematic illustrations ofseveral steps of another minimally-invasive closed sinus lift surgicalprocedure for implanting dental implant 30, in accordance with anapplication of the present invention. The procedure is typicallyemployed when a patient's maxillary alveolar ridge lacks sufficient bonemass to support a conventional dental implant. The procedure isparticularly appropriate for implanting the configuration of implant 30described hereinabove with reference to FIGS. 19A-D and 20A-G,optionally in combination with one or more of the features describedhereinabove with reference to FIGS. 2A-C and/or 28A-B.

A surgeon begins the procedure by drilling a preliminary bore portion inmaxillary alveolar ridge 200, such as described hereinabove withreference to FIG. 25A. After drilling the preliminary bore portion, thesurgeon advances dental implant 30 into the bore by screwing the implantinto ridge 200 using surgical rotation tool 90 (such as describedhereinabove with reference to FIGS. 1A and 1C), as shown in FIG. 26A. Inthis application, at this stage of the procedure, delivery tube 50 isnot yet coupled to implant 30. Because delivery tube 50 is not coupledto the implant, the surgeon can readily rotate the implant even ifadjacent teeth are present. This enables implantation of the implantwith the same intra-teeth distance possible in conventional implantationprocedures of conventional implants.

The surgeon typically screws the implant until distal implant end 38reaches the end of the osteotomy. The surgeon then advances the implantslightly (typically, by about one additional rotation), causing theimplant to break through the top of ridge 200 to below Schneiderianmembrane 222, thereby bringing distal opening(s) 41 into fluidcommunication with a surface of the membrane facing ridge 200, as shownin FIG. 26A. Distal implant end 38 typically does not pass through thetop of ridge 200, at least at this stage in the procedure. It is notedthat, if necessary to reach sufficient depth for the distal end of theimplant to reach the top of the ridge, the surgeon may advance theimplant so far as to advance all or a portion of lateral opening 44 intoridge 200. The implant is subsequently withdrawn in order to enableaccess to lateral opening 44, as described hereinbelow with reference toFIG. 26B.

Optionally, after the initial insertion of the implant into the bore,the surgeon uses a periapical radiograph to estimate remaining distancefrom implant tip to the sinus floor. The surgeon rotates the implant topenetrate into the sinus, such as by rotating the implant by a number ofrotations equal to the remaining distance divided by a constant, e.g.,1.2 mm. Optionally, the surgeon performs an additional periapicalradiograph to ensure that the implant has penetrated into the sinuscavity.

The surgeon ensures that upon the final rotation of implant 30, lateralopening 44 faces either in a lingual or buccal direction, in order toprovide access to the opening for coupling the retaining element, asdescribed immediately hereinbelow.

After the implant has been advanced to membrane 222, the surgeondecouples rotation tool 90 from applicator 32, and couples retainingelement 170 (described hereinabove with reference to FIGS. 19A-D and20A-G) to applicator 32, as shown in FIG. 26B. Supply tube 52 is coupledto the proximal end of delivery tube 50. At the initial time of couplingof retaining element 170 to applicator 32, the retaining element is inits second position, in which the distal end of delivery tube 50 is notcoupled to implant 30, as described hereinabove with reference to FIGS.19A-C and 20B. The surgeon then transitions retaining element 170 to itsfirst position, thereby coupling the distal end of the delivery tube tothe implant, such as described hereinabove with reference to FIGS. 19Dand 20C-D.

The surgeon gently lifts and separates membrane 222 from the top ofridge 200 into a maxillary sinus 228, by injecting a fluid 229, such asa biocompatible solution such as normal saline solution or a gas, fromfluid source 54 (optionally, under controlled pressure) via supply tube52, delivery tube 50, and lumen 40, so as to form a cavity 220 under themembrane between the ridge and the membrane (in FIG. 26B, the membraneis shown partially raised). Typically, the surgeon injects sufficientfluid 229 into cavity 220 to inflate the cavity to a vertical height ofbetween about 2 and about 20 mm from the top of ridge 200, such asbetween about 2 and about 11 mm, e.g., between about 2 and about 8 mm.For some applications, a measured volume of fluid 229 is injected inorder to achieve the desired cavity height, such as between about 0.5and about 6 ml of fluid, e.g., between about 1 and about 4 ml, betweenabout 1 and about 3 ml, or between about 2 and about 4 ml.

For some applications, the surgeon detects that membrane 222 hasdetached from the top of ridge 200 by observing blood within fluid 229,such as saline solution, returning from the sinus, as describedhereinabove with reference to FIG. 25C.

For some applications, the fluid is drained from the cavity, and thesurgeon injects a regenerative material 230, such as liquid or gel bonegraft, into cavity 220, as described hereinabove with reference to FIG.25D, mutatis mutandis. Alternatively, for some applications,regenerative material 230 is not injected into the cavity, i.e., thestep of the procedure described hereinabove with reference to FIG. 25Dis omitted. Fluid 229, which may comprise saline solution, is left incavity 220, or, alternatively, is drained from the cavity. Furtheralternatively, instead of injecting regenerative material 230, thesurgeon injects an alternative therapeutic material, such as one or amixture of more than one of the following materials: a bone growthstimulating substance, such as a bone morphogenetic protein (BMP), andblood. Still further alternatively, the surgeon injects regenerativematerial 230, rather than fluid 229, to lift membrane 222. In this case,the regenerative material typically comprises a liquid.

The surgeon transitions retaining element 170 back to its secondposition, as described hereinabove with reference to FIGS. 19A-C and20C-D, and decouples the retaining element from implant 30. Afterdecoupling delivery tube 50 from implant 30, the surgeon furtheradvances (e.g., by rotating or screwing) implant 30 into regenerativematerial 230 in cavity 220, as described hereinabove with reference toFIG. 25F. As described hereinabove with reference to FIG. 25G, afterbone grows in cavity 220 (into regenerative material 230, if injected)and is integrated into ridge 200, an appliance 140, such as a crown, iscoupled to implant 30, typically using an abutment 242 coupled toimplant 30, as is known in the art. Alternatively, as mentioned above,implant 30 comprises a single-stage transgingival implant/abutment, asis known in the art.

Optionally, the procedure is performed in combination with thetechniques described hereinabove with reference is made to FIGS. 25H-J.

Reference is made to FIGS. 27A and 27B, which are schematicillustrations of tools and techniques, respectively, for decouplingdelivery tube 50 from implant 30, in accordance with an application ofthe present invention. These tools and techniques are particularlyuseful for the configuration of delivery tube 50, implant 30, andapplicator 32 described hereinabove with reference to FIGS. 21A-24.

FIG. 27A shows a stabilization tool 250 and a driver tool 260. A distalend of the stabilization tool is shaped so as to define a couplingopening 252, having, for example, an internal hex width of 6.35 mm.Driver tool 260 may be a conventional hand driver having a hex width of2.4 mm, for example. For some applications, driver tool 260 is coupledto stabilization tool 250 within coupling opening 252, such that thedriver tool is rotatable with respect to the distal end of thestabilization tool.

As shown in FIG. 27B, the surgeon stabilizes applicator 32 by couplingstabilization tool 250 to the proximal end of the applicator. Applicator32, as shown hereinabove in FIGS. 21A-D and 22A-B, comprises anapplicator body, which comprises rotatable surface 92 accessible fromthe proximal end of the applicator. Applicator 32 is also shaped so asto define a stabilization surface 154 accessible from the proximal endof the applicator. Application of a stabilizing force to stabilizationsurface 154 stabilizes the implant during rotation of rotatable surface92. As a result, the decoupling of delivery tube 50 from implant 30 doesnot dislodge or misalign the implant, which has been precisely placed ina bore in the ridge, as described hereinabove with reference to FIG.25B. Furthermore, application of the stabilizing force reduces orprevents the transfer of force to the bone from tools operating on theapplicator and/or implant.

The outer diameter (or width, such as if the surface is hexagonal) ofthe stabilizing surface is approximately equal to the internal diameter(or width) of coupling opening 252 of stabilization tool 250, and thestabilizing surface and coupling opening have corresponding shapes.

The surgeon positions stabilization tool 250 such that coupling opening252 is removably coupled to stabilization surface 154, and applies thestabilizing force to stabilization surface 154. For example, both thecoupling opening and the stabilization surface may be hexagonal.Typically, rotatable surface 92 and stabilization surface 154 areconfigured to facilitate on-axis rotation of the rotatable surface,thereby minimizing any off-axis force that the rotation may cause theapparatus to apply to its surroundings.

In order to decouple delivery tube 50 from implant 30 by breakingthinner portion 72 of the delivery tube, while the stabilization toolstabilizes the applicator, the surgeon removably couples a driver tool260 to rotatable surface 92 of applicator 32 through opening 252 ofstabilization tool 250, and rotates the driver tool, thereby rotatingthe rotatable surface and breaking thinner portion 72, as describedhereinabove with reference to FIGS. 21A-24. For example, driver tool 260may be a conventional dental hand driver having a hex width of 2.4 mm.

Reference is made to FIGS. 27C and 27D-E, which are schematicillustrations of a tool and techniques for decoupling applicator 32 fromimplant 30, respectively, in accordance with an application of thepresent invention. This tool and these techniques are particularlyuseful for the configuration of delivery tube 50, implant 30, andapplicator 32 described hereinabove with reference to FIGS. 21A-24.

FIG. 27C shows a driver tool 262, such as a conventional hand driverhaving a hex width of 1.25 mm, for example.

As shown in FIG. 27D, the surgeon decouples applicator 32 from implant30 by inserting driver tool 262 into the head of connecting element 98,described hereinabove with reference to FIGS. 21A-24. The surgeonrotates driver tool 262 (typically counterclockwise) to unscrewconnecting element 98, thereby decoupling applicator 32 from implant 30.Typically, stabilizing tool 250 remains coupled to stabilization surface154 of implant 30 during this decoupling. FIG. 27E shows the applicatorafter it has been decoupled from the implant, leaving the implant inplace in the ridge.

For some applications, the techniques described herein are used forperforming nasal floor elevation, mutatis mutandis, in order to implanta dental implant in the incisor position. A bore is formed through amaxillary alveolar ridge in a region of the upper incisors from thefront side, and the implant is inserted into the bore at least until thedistal opening comes into fluid communication with a surface of a nasalfloor membrane facing the ridge. The membrane is raised to form a cavitybetween the ridge and the membrane.

For some applications, the techniques described herein are used with aninclined entry, for patients in which the residual bone of the maxillaryalveolar ridge is too thin to achieve stability. A bore is formed withan inclined entry at a location adjacent the site of the implant wherethere is sufficient bone, and sinus lift is performed via the bore usingthe techniques described herein, mutatis mutandis. For someapplications, the bore is formed using a biodegradable drilling elementthat is configured to biodegrade as the regenerative material integrateswith the native bone. Regenerative material is injected into the cavitybetween the ridge and the Schneiderian membrane. Prior to or after thematerial integrates, a second straight bore is made at the desiredimplant location through the thin preexisting bone and into theregenerative material or new bone, and a conventional implant isinserted into the bore.

For some applications, the techniques described herein are used with apalatal entry. A bore is formed in the palate (which is thicker than themaxillary alveolar ridge), and sinus lift is performed via the boreusing the techniques described herein, mutatis mutandis. For someapplications, the bore is formed using a biodegradable drilling elementthat is configured to biodegrade as the regenerative material integrateswith the native bone. The drilling element is withdrawn or allowed tobiodegrade. Regenerative material is injected into the cavity betweenthe ridge and the Schneiderian membrane. Prior to or after the materialintegrates, a second bore is made at the desired implant locationthrough the maxillary alveolar ridge and the new bone, and aconventional implant is inserted into the bore.

For some applications, the regenerative material comprises a compositioncomprising solid bone graft particles mixed with a physiologicalsolution, such as saline solution, blood, or diluted blood. For example,the solid bone graft particles may comprise freeze-dried bone allograft(FDBA). Typically, the volume concentration of the particles in thecomposition before filtering is less than 50%, e.g., less than 25%, suchas between about 10% and about 20%, as described below. For someapplications, two bores are formed through the maxillary alveolar ridgeto below the Schneiderian membrane. The regenerative material isinjected though a first bore, and at least a portion of thephysiological solution drains through a filter in (or in communicationwith) the second bore, leaving at least a portion of solid bone graftparticles in a cavity formed between the ridge and the membrane.Typically, the volume concentration of the particles in the compositionafter filtering is greater than 50%, e.g., between about 80% and about100%. For some applications, this technique is used for bones other thanthe maxillary alveolar ridge, such as a mandibular alveolar ridge.

Reference is made to FIGS. 28A-B, which are schematic lateral andhead-on illustrations, respectively, of a configuration of a distalsurface of dental implant 30, in accordance with an application of thepresent invention. For some applications, this configuration is used forimplants described hereinabove with reference to FIGS. 1A-C, 2A-C, 3A-D,4A-B, 15-18, 19A-D, 20A-G, and/or 21A-24. As described hereinabove withreference to FIGS. 1A-C, implant 30 is shaped so as to define a lumentherethrough that is open through at least one distal opening 41 todistal portion 48 of the implant that extends from distal implant end 38of the implant along up to 50% of a longitudinal length of the implant.Typically, the at least one opening is located at the center of thedistal implant end.

In the present configuration, distal portion 48 is shaped so as todefine at least one surface selected from the group consisting of: atleast one end mill cutter surface 800, at least one self-tapping surface802, and both the at least one end mill cutter surface and the at leastone self-tapping surface (as shown in FIGS. 28A-B). Unlike conventionalend mill and self-tapping surfaces, the end mill cutter and self-tappingsurfaces do not extend into a central area of the implant that definesthe lumen. This confining of the surfaces to the outer area of theimplant accommodates the distal opening and lumen. For someapplications, the end mill and self-tapping surfaces do not extend intoa cylindrical area 803, a central axis of which coincides with a centralaxis 804 of the implant, and which area extends along the entire lengthof the implant. Cylindrical area 803 typically has a diameter of atleast 0.3 mm, such as at least 0.5 mm, or at least 1.5 mm. For someapplications, the diameter of the lumen is between 0.3 and 2 mm, such asbetween 0.5 and 2 mm, e.g., between 1.5 and 1.6 mm. For someapplications, the greatest diameter of the implant (i.e., the diameterof the implant at its widest portion) is no more than 5 mm, such as nomore than 4.2 mm, or is between 3 and 6.5 mm.

The end mill cutter surface creates bone fragments and bone dust thatprotects the Schneiderian membrane or periosteal tissue as the implantis advanced through the bone. In addition, the end mill cutter surfacegrinds the bone of the ridge, which is generally effective for breakingthrough bone. Distal portion 48 both engages the lower portion of thebone while at the same time breaking through the upper portion of thebone.

For some applications, end mill cutter surface 800 is shaped so as todefine exactly two, exactly three, exactly four, exactly five, orexactly six cutting surfaces. For example, in the configuration shown inFIGS. 28A and 28B, end mill cutter surface 800 defines exactly threecutting surfaces 800A, 800B, and 800C, i.e., is tripartite, andself-tapping surface 802 defines exactly three self-tapping surfaces802A, 802B, and 802C. Typically, the cutting surfaces are distributedevenly about a central axis 804 of the implant, offset from the center.Lines 806 respectively defined by the cutting surfaces are typicallytangential to a circle 808 having a center which is intersected bycentral axis 804 of the implant (the circle may or may not have the sameradius as distal opening 41). Thus, for example, for applications inwhich the end mill cutter surface defines exactly two cutting surfaces802, lines 806 are parallel to one another; for applications in whichthe end mill cutter surface defines exactly three cutting surfaces 802,lines 806 form a triangle; and, for application in which the end millcutter surface defines exactly four cutting surfaces 802, lines 806 forma square.

For some applications, distal portion 48 is shaped so as to define aconical cross-section that is configured to cause bone condensation,which generally improves bone density.

Reference is made to FIGS. 29A-F, which are schematic illustrations ofseveral steps of a minimally-invasive closed lateral ridge augmentationsurgical procedure for implanting dental implant 30, in accordance withan application of the present invention. The procedure is typicallyemployed when a patient's maxillary or mandibular alveolar ridge 200lacks sufficient bone width to support a dental implant, as shown inFIG. 29A. For example, the procedure may be employed for implanting animplant to replace the upper canines, lower molars, upper incisors, orlower incisors.

The lateral ridge augmentation procedure may be performed with theconfiguration of implant 30 described hereinabove with reference toFIGS. 19A-D (as shown in and described hereinbelow with reference toFIGS. 29A-F), with the configuration of implant 30 described hereinabovewith reference to FIGS. 20A-G, or with the configuration of implant 30described hereinabove with reference to FIGS. 15-18. Alternatively thelateral ridge augmentation procedure may be performed with theconfiguration of implant 30 described hereinabove with reference toFIGS. 1A-3D, in which case the techniques described hereinbelow withreference to FIGS. 29A-F are performed in combination with thetechniques described hereinabove with reference to FIGS. 25A-G. Furtheralternatively, the lateral ridge augmentation procedure may be performedwith the configuration of implant 30 described hereinabove withreference to FIGS. 21A-24, in which case the techniques describedhereinbelow with reference to FIGS. 29A-F are performed in combinationwith the techniques described hereinabove with reference to FIGS. 27A-E.This closed lateral ridge augmentation surgical procedure may beperformed in combination with other techniques described herein. Forsome applications, the distal opening of the lumen is located on alateral surface of the implant near the distal end, rather than on thedistal end itself.

A surgeon begins the procedure by preparing the oral facial region, andadministering a local anesthetic. Optionally, the surgeon initiates anosteotomy in alveolar ridge 200 by making a preliminary portion of abore using a dental drill, such as a conventional sinus bur. Thispreliminary bore portion typically has a diameter of between about 1 andabout 7 mm, e.g., between about 2 and about 6 mm. Optionally, thesurgeon widens the bore using a series of successively wider drill bits,until a desired bore diameters is achieved (for example, the largestdrill bit may have a diameter of 3.65 mm for an implant having adiameter of 4.2 mm, or a diameter of 4.2 mm for an implant having adiameter of 5 mm). The bore may be measured using techniques known inthe art, such as CT, x-ray, or x-ray with a depth guide. For someapplications, a surgical guide is used to ensure clearance between thecenter of the osteotomy and the nearest tooth surfaces. Optionally, apre-surgery radiograph (e.g., CT or x-ray) is performed, to enable thesurgeon to estimate the necessary depth of the osteotomy.

After drilling the preliminary bore portion, the surgeon advances dentalimplant 30 into the bore by screwing the implant into ridge 200 usingsurgical rotation tool 90 coupled to applicator 32, as describedhereinabove with reference to FIGS. 1A and 1C.

As shown in FIG. 29B, the surgeon inserts implant 30 into the bore atleast until the distal opening comes into fluid communication withperiosteal tissue 340 covering a lateral surface of the bone.

After the implant has been advanced, the surgeon decouples rotation tool90 from applicator 32, and couples retaining element 170 (describedhereinabove with reference to FIGS. 19A-D and 20A-G) to applicator 32,as shown in FIG. 29C. Supply tube 52 is coupled to the proximal end ofdelivery tube 50. At the initial time of coupling of retaining element170 to applicator 32, the retaining element is in its second position,in which the distal end of delivery tube 50 is not coupled to implant30, as described hereinabove with reference to FIGS. 19A-C and 20B. Thesurgeon then transitions retaining element 170 to its first position,thereby coupling the distal end of the delivery tube to the implant, asdescribed hereinabove with reference to FIGS. 19D and 20C-D.

The surgeon delaminates periosteal tissue 340 from the bone by injectingfluid 229 from fluid source 54 via supply tube 52, delivery tube 50, andlumen 40 of the implant, to form a cavity 320 between the bone andperiosteal tissue 340, as shown in FIG. 29C.

For some applications, the fluid is drained from the cavity, and thesurgeon injects a regenerative material 230, such as liquid or gel bonegraft, into cavity 320, as shown in FIG. 29D. Fluid source 54 or aseparate syringe or powered drug delivery device is used for injectingthe regenerative material. If a separate syringe or device is used toinject the material, the material may be provided via supply tube 52, orvia a separate supply tube. Regenerative material 230 may comprise anyof the materials mentioned hereinabove with reference to 25D Optionally,the system monitors and generates an output indicative of the pressureof the regenerative material as it is injected. Alternatively, for someapplications, regenerative material 230 is not injected into the cavity.Fluid 229, which may comprise saline solution, is left in cavity 320,or, alternatively, is drained from the cavity. Further alternatively,instead of injecting regenerative material 230, the surgeon injects analternative therapeutic material, such as one or a mixture of more thanone of the following materials: a bone growth stimulating substance,such as a bone morphogenetic protein (BMP), and blood. Still furtheralternatively, the surgeon injects regenerative material 230, ratherthan fluid 229, to determinate periosteal tissue 340. In this case, theregenerative material typically comprises a liquid.

For some applications, the system measures the volume of fluid 229injected into the cavity while forming the cavity, at the step of theprocedure described hereinabove with reference to FIG. 29C. Responsivelyto the measured volume, the surgeon determines an amount of regenerativematerial 230 to inject into cavity 320 at the step of the proceduredescribed hereinabove with reference to FIG. 29D. Typically, the amountof regenerative material 230 is approximately equal to the volume ofinjected fluid 229, or slightly greater or less than the volume of theinjected fluid. As a result, waste of regenerative material 230 isgenerally minimized.

For some applications, the surgeon uses a flexible wire as a piston tohelp push the regenerative material through the supply tubes and/orlumen. This technique may be helpful when the regenerative material isviscous and thus difficult to inject using an ordinary syringe.

The surgeon transitions retaining element 170 back to its secondposition, as described hereinabove with reference to FIGS. 19A-C and20C-D, and decouples the retaining element from implant 30. Afterdecoupling delivery tube 50 from implant 30, the surgeon furtheradvances (e.g., by rotating or screwing) implant 30 into regenerativematerial 230 in cavity 320, as shown in FIG. 29E. This additionaladvancing of the implant advances the lateral surface of implant 30 atleast until lateral opening 44 is positioned entirely within the bore inridge 200 and/or in regenerative material 230 in cavity 320. Suchpositioning of both ends of the lumen within bone substantially reducesthe risk of infection, because the proximal end of implant 30 that isexposed to the oral cavity or gingiva is permanently closed.

The surgeon decouples applicator 32 from implant 30, such as by pullingthe male coupling element out of the female coupling element, or usingthe tool and techniques described hereinabove with reference to FIG.27C-E. Typically, the surgeon couples a cover screw to the proximal endof the implant using a hand driver, and sutures the gingiva.

As shown in FIG. 29F, bone grows in cavity 220 (into regenerativematerial 230, if injected) and is integrated into ridge 200. Thereafter,an appliance, such as a crown, is coupled to implant 30, typically usingan abutment coupled to the implant, as is known in the art.Alternatively, implant 30 comprises a single-stage transgingivalimplant/abutment, as is known in the art.

Reference is now made to FIG. 30, which is a schematic illustration of aconfiguration of sealing element 187 of retaining element 170, inaccordance with an application of the present invention. Althoughillustrated for the configuration of retaining element 170 describedhereinabove with reference to FIGS. 20A-G, this configuration of sealingelement 187 may also be used for the configuration of retaining element170 described hereinabove with reference to FIGS. 15, 16, 17A-E, and 18and FIGS. 19A-D.

In this configuration, retaining element 170 comprises sealing element187 at the distal end of delivery tube 50. Typically, the distal end ofdelivery tube 50 is embedded in sealing element 187. Delivery tube 50includes an increased-diameter distal portion 400, which may bedisc-shaped, which helps couple tube 50 to sealing element 187, andforms a surface that applies even pressure to the sealing element,thereby helping the sealing element to seal with lateral opening 44 ofthe implant. The sealing element may also be coupled to the tube usingan adhesive. Sealing element 187 typically comprises silicone, siliconerubber, or another biocompatible compliant sealing material. For someapplications, a distal portion 402 of sealing element 187 is conical.For example, distal portion 402 may be shaped as a cone that has anopening angle of between 0 and 90 degrees, such as between about 15 andabout 75 degrees, e.g., between about 15 and about 60 degrees.

Reference is now made to FIG. 31, which is a schematic illustration of aremovable coupling element 500 coupled to a dental implant 530, inaccordance with an embodiment of the present invention. Implant 530 isgenerally similar to implant 30, described hereinabove, and mayimplement all or a portion of the features thereof. In particular,implant 530 is shaped so as to define lumen 40 therethrough that is openthrough distal opening 41 to a distal portion of the implant. A proximalend of lumen 40 has a lateral opening 44 through a lateral externalsurface of the implant.

Removable coupling element 500 removably secures a delivery tube 550 tolateral opening 44. When the surgeon decouples delivery tube 550 fromimplant 530, the surgeon also decouples coupling element 500 from theimplant. The coupling element is typically removably coupled to anexternal surface of the implant. For some applications, coupling element500 is configured to be placed around at least a portion of thecircumference of the implant, such as the entire circumference.

In an embodiment, coupling element 500 comprises an elastic band that isplaced around the entire circumference of the implant, as shown in FIG.31. The distal end of delivery tube 550 may pass through an opening inthe band, such that the band holds the tube in place coupled to lateralopening 44. For other applications, coupling element 500 comprises amore rigid material.

Reference is now made to FIGS. 32A-C, which are schematic illustrationsof implant 30 and dental applicator 32, in accordance with anapplication of the present invention. FIG. 32A is an isometric view ofthe implant and applicator, and FIGS. 32B and 32C are cross-sectionalviews of FIG. 32A along lines XXXIIB-XXXIIB and XXXIIC-XXXIIC,respectively. In this configuration, applicator 32 is shaped so as todefine:

-   -   a distal coupling surface 600, which is configured to removably        engage applicator 32 with a proximal end 602 of dental implant        30;    -   a proximal coupling surface 604; and    -   a longitudinal portion 606, which is shaped so as to define an        external surface 608 that is rotationally asymmetric.        Distal and proximal coupling surfaces 600 and 604 share a common        central longitudinal axis 610. Because of this common axis,        rotation of proximal coupling surface 604 causes corresponding        rotation of distal coupling surface 600.

As used in the present application, including in the claims, athree-dimensional surface is “rotationally symmetric” if the surface hasn-fold (also called n-order) rotational symmetry with respect to anaxis, wherein n is greater than (and not equal to) 1, such that rotationof the surface by an angle of 360°/n does not change the appearance ofthe surface. For example, all regular polygonal right cylinders andcircular right cylinders are rotationally symmetric. A three-dimensionalsurface is “rotationally asymmetric” if it is not rotationallysymmetric.

(By way of simplified example in two dimensions, a two-dimensional shapeis rotationally symmetric if the shape has n-fold rotational symmetrywith respect to a point, wherein n is greater than (and not equal to) 1,such that rotation of the shape by an angle of 360°/n does not changethe appearance of the shape. For example, circles and all regularpolygons (e.g., equilateral triangles, squares, and regular pentagons)are rotationally symmetric, while trapezoids are rotationallyasymmetric).

Reference is made to FIG. 33, which is a schematic cross-sectionalillustration showing retaining element 170 removably coupled toapplicator 32, in accordance with an application of the presentinvention. For some applications, a retaining element, such as retainingelement 170, described hereinabove with reference to FIGS. 20A-F, isremovably coupled to applicator 32. The retaining element is shaped suchthat rotationally-asymmetric surface 608 of applicator 32 constrains arotational orientation of the retaining element with respect to theapplicator, such that the retaining element can only be removablycoupled to the applicator at a single rotational orientation withrespect to the applicator. Such rotational constraint typically servesto rotationally align the distal end of delivery tube 50 with lateralopening 44 of implant 30.

Reference is again made to FIGS. 32A-C. Typically, distal couplingsurface 600 extends from a distal end 620 of applicator 32 towardproximal coupling surface 604 (although distal coupling surface 600typically does not reach proximal coupling surface 604). Alternativelyor additionally, proximal coupling surface 604 extends from a proximalend 622 of applicator 32 toward distal coupling surface 600 (althoughproximal coupling surface 604 typically does not reach distal couplingsurface 600).

Typically, distal coupling surface 600 is rotationally symmetric and notcircular, to enable the surface to engage a coupling surface of theimplant. For example, distal coupling surface 600 may be regularlypolygonally shaped, such as a hexagonally or an octagonally shaped.Alternatively or additionally, proximal coupling surface 604 isrotationally symmetric and not circular, to enable the surface to engagea tool, such as a wrench. For example, proximal coupling surface 604 maybe regularly polygonally shaped, such as a hexagonally or a squarelyshaped.

For some applications, distal coupling surface 600 is longitudinallynon-overlapping with rotationally-asymmetric external surface 608.Alternatively or additionally, for some applications proximal couplingsurface 604 is longitudinally non-overlapping withrotationally-asymmetric external surface 608.

Typically, distal coupling surface 600 is male (as shown) or female (notshown). Alternatively or additionally, proximal coupling surface 604 ismale (as shown) or female (not shown). Further alternatively oradditionally, proximal coupling surface 604 is shaped so as tosimultaneously define both male and female coupling elements (notshown).

For some applications, applicator 32 is shaped so as to define a channel630 therethrough, which is open to both distal and proximal ends 620 and622 of applicator 32, and which is coaxial with central longitudinalaxis 610. The applicator may comprise connecting element 98, which isconfigured to be disposed at least partially in channel 630, and toremovably couple the applicator to proximal implant end 602. For someapplications, connecting element 98 comprises a shaft 632, at least aportion of which defines a screw thread 634. The screw thread engages athreaded coupling surface 636 of implant 30 (which may be more distallydisposed than a coupling surface 638 of the implant which distalcoupling surface 600 engages).

Alternatively (configuration not shown), rotationally-asymmetricexternal surface 608 extends from distal end 620 of applicator 32 towardproximal end 622 of applicator 32 (although surface 608 does notnecessarily reach proximal end 622). In this case, distal couplingsurface 600 is typically female, and longitudinally overlapsrotationally-asymmetric external surface 608. Alternatively oradditionally (configuration not shown), rotationally-asymmetric externalsurface 608 extends from proximal end 622 of applicator 32 toward distalend 620 of applicator 32 (although surface 608 does not necessarilyreach distal end 620). In this case, proximal coupling surface 604 istypically female, and longitudinally overlaps rotationally-asymmetricexternal surface 608. In an application of the present invention, adental applicator is provided that has the configuration of dentalapplicator 32 described hereinabove with reference to FIGS. 32A-C and33, except that external surface 608 of longitudinal portion 606 has2-fold rotational symmetry. The retaining element thus can be removablycoupled to the applicator at exactly two rotational orientations withrespect to the applicator.

In some applications of the present invention, a dental surgical methodis provided that comprises:

-   -   (a) implanting a first set of dental implants in a maxillary        alveolar ridge anterior to the maxillary sinus, and assembling a        first dental prosthesis on the first implants;    -   (b) performing a sinus lift, optionally using any of the sinus        lift techniques described herein, and implanting a second set of        one or more implants, such as dental implants 30, in the ridge        posterior to the first set of implants, in the vicinity of the        sinus lift; at this stage of the procedure, no dental prostheses        are assembled on the second set of implants; and    -   (c) subsequently to steps (a) and (b) (typically at least four        months thereafter, such as at least six months thereafter),        assembling a second prosthesis on both the first and the second        sets of implants, i.e., the first set of implants anterior to        the sinus and the second set of implants implanted in        conjunction with the sinus lift; the second prosthesis may be        entirely separate from the first prosthesis, or may comprise a        portion of the first prosthesis.        Step (a) may be performed before or after step (b).

As is well known in the art, an all-on-four dental implant procedure isgenerally used in cases in which all of the teeth are missing in a jaw(usually the upper jaw). The all-on-four dental implant procedure servesas an alternative to a sinus lift (many patients would prefer not toundergo a sinus lift). The entire rehabilitation is built on fourimplants, two at anterior site of the maxillary alveolar ridge and twoangled a posterior site of the ridge. This technique has the advantageof a quick rehabilitation without sinus surgery, but the disadvantage ofan inferior long-term solution compared with a more solid foundationbased on six or eight implants including implants in the posteriorregion of the jawbone. Similar techniques may use more than fourimplants, but they are still limited to implants placed in the region ofthe jawbone which is anterior to the maxillary sinus.

In some applications of the present invention, the dental surgicalmethod described two paragraphs above comprises performing anall-on-four dental implant procedure in combination with a sinus liftprocedure described herein and/or in the applications incorporated byreference hereinbelow. At step (a) of the method, an all-on-fourprocedure is performed by implanting the first set of implants, two atanterior site of the maxillary alveolar ridge and two angled a posteriorsite of the ridge, and a first dental prosthesis is assembled on thefirst set of implants. At step (b) of the method, during the sinus liftprocedure, a second set of one or more dental implants, such as dentalimplant 30, are implanted, but are not yet used for supporting a dentalprosthesis. Typically, the all-on-four procedure and the sinus liftprocedure are performed during a first, single surgical procedure.Alternatively, they may be performed in separate surgical procedures.The patient receives temporary rehabilitation using the all-on-fourmethod. Typically at least four months (e.g., about six to nine months)after the first surgical procedure, a second surgical procedure isperformed, in which the temporary all-on-four first prosthesis is fullyor partially replaced with a second prosthesis that provides a permanentrestoration assembled on the first set of implants, as well as on theadditional second set of one or more implants implanted during the sinuslift procedure. As a result, the patient receives a stable, long-termsolution.

The scope of the present invention includes embodiments described in thefollowing patent applications, which are assigned to the assignee of thepresent application and are incorporated herein by reference. In anembodiment, techniques and apparatus described in one or more of thefollowing applications are combined with techniques and apparatusdescribed herein:

-   -   U.S. application Ser. No. 12/240,353, filed Sep. 29, 2008, which        issued as U.S. Pat. No. 7,934,929;    -   U.S. application Ser. No. 12/485,199, filed Jun. 16, 2009, which        issued as U.S. Pat. No. 8,029,284;    -   International Application PCT/IL2009/000931, filed Sep. 29,        2009, which published as PCT Publication WO 2010/035270;    -   International Application PCT/IL2010/000252, filed Mar. 24,        2010, which published as PCT Publication WO 2010/146573; and/or    -   U.S. application Ser. No. 12/661,795, filed Mar. 24, 2010, which        published as US Patent Application Publication 2010/0255446.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-32. (canceled)
 33. Apparatus comprising: a dental implant having alateral external surface, the implant being shaped so as to define alumen therethrough having a lateral opening through the lateral externalsurface; a delivery tube having a distal tube end, which is removablycoupled to the implant such that the delivery tube is in fluidcommunication with the lumen via the lateral opening; and a fixingelement and a fixing element receptor, which are configured to betemporarily coupled together so as to prevent decoupling of the deliverytube from the implant.
 34. The apparatus according to claim 33, furthercomprising an applicator, which is removably coupled to a proximalimplant end of the implant, and which is shaped so as to define thefixing element receptor.
 35. The apparatus according to claim 34,wherein the applicator is configured such that removal of the applicatorfrom the implant frees the fixing element from the fixing elementreceptor.
 36. The apparatus according to claim 33, wherein the deliverytube comprises the fixing element.
 37. The apparatus according to claim33, wherein the fixing element and the fixing element receptor areconfigured, when temporarily coupled together, to prevent rotation ofthe delivery tube with respect to the implant.
 38. The apparatusaccording to claim 33, wherein the fixing element is shaped so as todefine a fixing pin, and the fixing element receptor is shaped so as todefine a receptor hole.
 39. The apparatus according to claim 33, whereinthe fixing element is shaped so as to define a shape selected from thegroup consisting of: a slot and a groove, and the fixing elementreceptor is shaped so as to define a corresponding coupling surface thatfixes the fixing element to the fixing element receptor. 40-46.(canceled)
 47. Apparatus comprising: a dental implant; and a dentalapplicator, which is shaped so as to define: a distal coupling surface,which is configured to removably engage the applicator with a proximalend of the dental implant, a proximal coupling surface, and alongitudinal portion, which is shaped so as to define an externalsurface that is rotationally asymmetric, wherein the distal and theproximal coupling surfaces share a common central longitudinal axis. 48.(canceled)
 49. The apparatus according to claim 47, wherein the distalcoupling surface extends from a distal end of the applicator toward theproximal coupling surface.
 50. The apparatus according to claim 47,wherein the proximal coupling surface extends from a proximal end of theapplicator toward the distal coupling surface.
 51. The apparatusaccording to claim 50, wherein the distal coupling surface extends froma distal end of the applicator toward the proximal coupling surface.52-55. (canceled)
 56. The apparatus according to claim 47, wherein eachof the distal and the proximal coupling surfaces is rotationallysymmetric and not circular.
 57. (canceled)
 58. The apparatus accordingto claim 47, wherein the distal coupling surface is longitudinallynon-overlapping with the rotationally-asymmetric external surface. 59.The apparatus according to claim 47, wherein the proximal couplingsurface is longitudinally non-overlapping with therotationally-asymmetric external surface.
 60. The apparatus according toclaim 47, wherein the distal and the proximal coupling surfaces arelongitudinally non-overlapping with the rotationally-asymmetric externalsurface.
 61. The apparatus according to claim 60, wherein the distal andthe proximal coupling surfaces are male and regularly polygonallyshaped. 62-63. (canceled)
 64. The apparatus according to claim 47,wherein the applicator is shaped so as to define a channel therethrough,which is open to both distal and proximal ends of the applicator, andwhich is coaxial with the central longitudinal axis.
 65. The apparatusaccording to claim 64, wherein the applicator comprises a connectingelement, which is configured to be disposed at least partially in thechannel, and to removably couple the applicator to the proximal implantend.
 66. The apparatus according to claim 65, wherein the connectingelement comprises a shaft, at least a portion of which defines a screwthread. 67-94. (canceled)